meca-risk-management-guidance---report--- medical devices iec-60601-1-ed.-3---rev.0.0

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Risk Management Guidance & Report:

IEC 60601-1:2005 Medical electrical equipment - Part1: General requirements for basic safety
and essential performance
© 2012 Medical Equipment Compliance Associates - All Rights Reserved
An editable version of this document is available to MECA customers - please contact us

5060 W. Ashland Way Franklin, Wisconsin 53132 United States Phone No. 262-752-4017 http://www.60601-1.com
Table of Contents
Risk Management Guidance & Report: .................................................................................................. 1
Purpose........................................................................................................................................................ 3
Scope ........................................................................................................................................................... 3
General Information ................................................................................................................................... 3
Definitions and Acronyms ......................................................................................................................... 4
Definitions ................................................................................................................................................ 4
Acronyms ................................................................................................................................................. 4
Table 2: Acronyms..................................................................................................................................... 4
References .................................................................................................................................................. 5
Internal References: .................................................................................................................................. 5
External References: ................................................................................................................................. 5
Report & Template Ownership and Revision History ........................................................................... 5
Template Prepared By........................................................................................................................... 5
Template Revision History .................................................................................................................... 5
Report Prepared By ............................................................................................................................... 5
Report Revision History......................................................................................................................... 5
Instructions for completing Table 3 .............................................................................................................. 6
Figure 1: Example Risk Table..................................................................................................................... 7
Table 3 Risk Management Results Tables ..................................................................................................... 8
Risk Management Assessment Tracking: .................................................................................................. 142
Table 4 Documentation Review Tracking ............................................................................................. 142
Table 5 Risk Management Non-Conformity Tracking ........................................................................... 143
Software (PEMS) Assessment Tracking: .................................................................................................... 144
Table 6 Inventory of documents for PEMS - Clause 14......................................................................... 144
Table 6 PEMS Non-Conformity Tracking ............................................................................................... 150

Purpose
The purpose of this form is to document the objective evidence required to show
compliance with the Risk Management requirements from the referenced standard(s).
This document also provides guidance on these requirements as they relate to the Risk
Management Processes and the referenced standard(s).
Scope
This document provides a summary of the Risk Management Requirements listed in IEC
60601-1:2005, along with the required risk management documentation required by
Revision G of the IECEE Test Report From and IECEE CB Scheme Operational
Document OD2044 Rev. 1.
This document maps to the location of the required objective evidence within the
document control system for the product/product families listed below. A full listing of all
accessories, parts, versions (including software) can be found in the TRF/Report.
Product/Product Family Version, Configuration etc.
General Information
The following items outline general rules used throughout this document.
References to clauses within the standard are preceded by the term clause followed by
the clause number. References to subclauses within the standard are by number only.
In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if
any combination of the conditions is true.
The verbal forms used in this document conform to usage described in Annex H of the
ISO/IEC Directives, Part 2. For the purposes of this standard, the auxiliary verb:
“Shall” means that compliance with a requirement or a test is mandatory for compliance
with this standard.
“Should” means that compliance with a requirement or a test is recommended but is not
mandatory for compliance with this standard.
“May” is used to describe a permissible way to achieve compliance with a requirement or
test.
NOTE: This document is not a replacement for the standard, it does not include the full text of any
referenced requirements, specifically NOTEs, EXAMPLES and Test Requirements.

Definitions and Acronyms

Definitions
Below are the definitions of terms used within this document.
Term Definition
Clause (of standard) One of the numbered divisions within the table of
contents, inclusive of all subdivisions (e.g. Clause 4
includes sub-clauses 4.1, 4.2, etc.).
Subclause (of A numbered subdivision of a clause (e.g. 4.1, 4.2
standard) and 4.10.1 are all sub-clauses of Clause 4).
Risk Management A process complying with ISO 14971
Process
Design Control A process complying with Clause 7 of ISO 13485
Process
Usability Engineering A process complying with either IEC 60601-1-6 or
Process IEC 62366
NOTE: All definitions of IEC 60601-1:2005, ISO 14971:2000 apply
Acronyms
Below are the acronyms used within this document.
Table 1: Acronyms
Acronym Term
DHF Design History File (Technical File)
IEC International Electrotechnical Commission
ISO International Organization for Standardization
MEE Medical Electrical Equipment
MES Medical Electrical Systems
NCB National Certification Body
RMF Risk Management File
RM Risk Management
SDLC Software Development Life-Cycle (See IEC 62304)

References
Internal References:
External References:
IEC 60601-1:2005 Medical Electrical Equipment - Part 1: General requirements for basic safety
and essential performance
IECEE Test Report Form No IEC60601_1G
IECEE Operational Document OD-2044-Ed.1.0
Report & Template Ownership and Revision History

Template Prepared By
Alex Grob, Chief Biomedical Engineer
Template Revision History

Table 1: Revision History
Revision Reason for Change or Change Control Document Author Date
Number Number
0.0 Initial Release Alex Grob 12-Jan-2012
0.1 Correction - changed clause 9.4.2.3 to Jeremi Peck 10-Feb-2012
9.4.3.2, moved header and footers
Report Prepared By
<Enter Document Owner>
Report Revision History

Table 2: Revision History
Revision Reason for Change or Change Control Document Author
Number Number

Instructions for completing Table 3

The purpose of the following tables is to identify the clauses of IEC 60601-1 that interact
with the risk management process, state the requirement, and provide guidance on what
is required to prove compliance. The tables below are 2-part tables, the top section of
the table identifies the requirement and guidance, along with a place to identify the
quality system document (section, page...as precise as possible) where the objective
evidence can be found and a verdict for the clause (Pass (P), Fail (F), Not Applicable
(NA), Not Evaluated (NE)). The bottom section of the table contains the risk
management tables required to be completed for each clause according to the IECEE
Test Report Form, and the IECEE CB Scheme Operational Document OD2044. These
tables are intended to identify the process requirement (steps) from ISO 14971:2000 that
are related to the requirement from IEC 60601-1:2005. NOTE: Only clauses from ISO
14971:2000 that have been identified in the IECEE TRF and OD244 will be listed for
each clause. See Figure 1 below for an example.
The “guidance” column identifies general guidance on the applicability of the
requirement and/or recommendations on how this requirement should be addressed in
specific product designs. There is no user action required on this column. NOTE: any
text in blue font (Blue, Accent 1) is taken from the IECEE OD2044 document.
The “Objective Evidence” column should be filled in (where appropriate) by the user of
this form. This column should contain either a statement of compliance which answers
the requirement completely, or a link to an internal document (e.g. Risk Management
File, Verification Plan, Validation Report) where the evidence showing compliance with
this requirement is maintained for the product(s) covered by this document.
For each applicable clause, review the requirement summary & guidance columns, enter
any comments necessary to explain the verdict or providing the reference to important
documents in the top section of the table (IEC 60601-1:2005 Clause Requirement). In
the lower section of the table, enter the links to the corresponding risk management file
location where the required evidence can be found to satisfy the requirement from ISO
14971:2000 related to the IEC 60601-1:2005 requirement. If a specific clause does not
apply to your product, enter a verdict of NA in the top section and leave the rest of the
table blank. Other verdicts will be filled in by your MECA contact once we have
completed our review of the referenced documents and any necessary testing.
Tables with a yellow background are required for all equipment types where the clause
is applicable. All these tables are required to complete an evaluation unless the clause
verdict is NA.
When filling out the Table for Clause 4.2, the expectation is that the document
references will be to Quality System Procedures & Work Instructions. When completing
the remainder of the tables, the expectation is that the references will be to Quality
System Records specific to the Product/Product Family that is under evaluation.

Figure 1: Example Risk Table

Table 3 Risk Management Results Tables

IEC 60601-1:2005 Requirement
IEC 60601-1 Clause Requirement Summary Guidance Comment Verdict
4.2 RISK MANAGEMENT A RISK MANAGEMENT PROCESS Compliance with this requirement is NE
PROCESS for ME EQUIPMENT and complying with ISO 14971 shall be achieved through application a Risk
ME SYSTEMS performed. Management Process
In applying ISO 14971:
— The term “medical device” shall Is a risk management process in
assume the same meaning as ME accordance with ISO 14971 in pace?
EQUIPMENT or ME SYSTEM.
— The term “fault conditions” referred Was this process used for the device
to in ISO 14971 shall include, but shall being evaluated?
not be limited to, SINGLE FAULT
CONDITIONS identified in this Are all risk management procedures
standard. developed and applied for the device
— The policy for determining being evaluated?
acceptable RISK and the acceptability
of the RESIDUAL RISK(s) shall be Is there a risk management plan?
established by the MANUFACTURER.
— Where this standard or any of its Has the overall residual risk been
collateral or particular standards evaluated as acceptable?
specify verifiable requirements
addressing particular RISKS, and
these requirements are complied with,
the RESIDUAL RISKS addressed by
these requirements shall be presumed
to be acceptable unless there is
OBJECTIVE EVIDENCE to the
contrary.
Compliance is checked by inspection

of the RISK MANAGEMENT FILE. The
requirements of this clause and all
requirements of this standard referring
to inspection of the RISK
MANAGEMENT FILE are considered
to be satisfied if the MANUFACTURER
has:
— established a RISK MANAGEMENT
PROCESS;
© 2012 Medical Equipment Compliance Associates - All Rights Reserved Experts in the field of medical
certification and regulatory
An editable version of this document is available to MECA customers - please contact us compliance with a commitment
to quality service
— established acceptable levels of

RISK; and
— demonstrated that the RESIDUAL
RISK(s) is acceptable (in accordance
with the policy for determining
acceptable RISK).
Related ISO 14971:2000 Requirement(s)
ISO 14971 Clause Document Ref. in Results - Remark Verdict Guidance
RMF (page, section)
3.3a - risk acceptability policy NE
3.5e - criteria for risk acceptability NE
4.1 - Risk Analysis NE
4.2 - Intended Use/Purpose NE
4.3 - Hazard Identification NE
4.4 - Risk Estimation NE
5 - Risk Evaluation NE
6.1 - Risk Reduction NE
6.2 - Option Analysis NE
6.3 - Implementation of Risk Control NE
6.4 - Residual Risk Evaluation NE
6.5 - Risk/Benefit Analysis NE
6.6 - Other generated hazards NE
6.7 - Completeness evaluation NE
7 - Overall Residual Risk NE

4.3 ESSENTIAL PERFORMANCE The MANUFACTURER shall identify The DHF should include an assessment NE
which functions of the ME of what functional performance is
EQUIPMENT and ME SYSTEMS are ESSENTIAL PERFORMANCE.
ESSENTIAL PERFORMANCE. Guidance can be found in many of the
Where this standard specifies that Particular Standards (IEC 60601-2-xx).
ESSENTIAL PERFORMANCE is to be
maintained following a particular test, Have hazardous situations been
the functions determined above shall identified where the residual risk
be used and compliance shall be becomes unacceptable due to the loss
checked by inspection, and if or degradation of performance?
necessary, by functional test.
Have these performance
Compliance is checked by inspection (characteristics) been identified as
of the RISK MANAGEMENT FILE. essential performance?
to quality service
Have risk control measures or tests

been identified to confirm essential
performance is maintained?
Have these items been confirmed

through inspection or test?
RMF (page, section)

4.4 EXPECTED SERVICE LIFE The MANUFACTURER shall state the The EXPECTED SERVICE LIFE of the NE
EXPECTED SERVICE LIFE of the ME equipment should be identified in the
EQUIPMENT or ME SYSTEM in the DHF.
RISK MANAGEMENT FILE.
Has the expected service life been
Compliance is checked by inspection identified?
of the RISK MANAGEMENT FILE.
RMF (page, section)

4.5 Equivalent safety for ME Where this standard specifies If a the device will contain constructions NA
EQUIPMENT or ME SYSTEMES requirements addressing particular which do not comply with the stated
RISKS, alternative means of requirements in this standard, or any of
addressing these RISKS are the requirements of this standard are
acceptable provided that the modified, it should be clearly identified
MANUFACTURER can justify that the in the documentation (generally
RESIDUAL RISKS that result from Verification Test Reports) what the
applying the alternative means are deviation/modification was. Generally,
equal to or less than the RESIDUAL if compliance with this standard is
RISKS that result from applying the referenced as a risk mitigation in the
to quality service
requirements of this standard. RMF it is assumed that the documented

Compliance is checked by inspection deviation/modification is acceptable for
of the RISK MANAGEMENT FILE. mitigating the referenced risk.
The assessment should clearly identify
that the risk assumed by not complying
with the standard is acceptable.
Are there particular risks for which

alternative means of controlling the risk
are applied?
Were these risks deemed acceptable?
Is the resulting residual risk equal to or

less than the residual risk of directly
applying the requirements of IEC
60601-1 (including partiulars &
collaterals)?
RMF (page, section)

4.6 ME EQUIPMENT or ME The RISK MANAGEMENT PROCESS The APPLIED PART consists of only NE
SYSTEM parts that contact the shall include an assessment of the parts which must be in contact with
PATIENT whether parts that can come into the PATIENT for the device to perform
contact with the PATIENT but fall it’s intended use.
outside of the definition of APPLIED Parts which are or may be in contact
PARTS shall be subject to the with the PATIENT based on the device
requirements for APPLIED PARTS. If construction (not that they need to be
the RISK MANAGEMENT PROCESS for the device to function properly) must
determines that such parts are subject be reviewed to determine if the only
to quality service
to the requirements for APPLIED acceptable method to minimize the

PARTS, then all the relevant RISKS to the PATIENT is for those
requirements and tests of this standard parts to be treated (designed/tested) as
shall apply, except that 7.2.10 does if they were APPLIED PARTS.
not apply to such parts. This assessment should be
documented in the DHF as part of the
Compliance is checked by inspection design input phase. And should also
of the RISK MANAGEMENT FILE. include an assessment if the part
should meet the requirements of type B,
BF or CF.
Have parts been identified during the

risk management process that can
come into contact with the patient but
fall outside the definition of applied
parts?
Are the relevant requirements and tests

of IEC 60601-1 applied?
Are there residual risks deemed not

acceptable?
Are there risk control meausres

implemented making the residual risk
acceptable?
RMF (page, section)

4.7 SINGLE FAULT CONDITION for ME EQUIPMENT shall be so designed Evidence supporting compliance with NE
to quality service
ME EQUIPMENT and manufactured that it remains this clause should be found in design
SINGLE FAULT SAFE, or the RISK input documentation as well as
remains acceptable as determined verification test reports documenting
through application of 4.2. compliance with this standard.
ME EQUIPMENT is considered As noted in relation to clause 4.5 of this
SINGLE FAULT SAFE if: standard; listing of this standard as a
a) it employs a single means for risk mitigation with tracability to a
reducing a RISK that has a negligible design output (e.g.; verification test
probability of failure (e.g., report) which clearly defines how the
REINFORCED INSULATION, standard was applied to a specific
suspended masses without product is sufficient for showing
MECHANICAL PROTECTIVE compliance with this requirement.
DEVICES employing a TENSILE
SAFETY FACTOR of 8X, Are there single fault conditions which
COMPONENT WITH HIGH- lead directly to hazardous situations
INTEGRITY CHARACTERISTICS), or described in clause 13.1 of IEC 60601-1
b) a SINGLE FAULT CONDITION or to other risks that are unacceptable?
occurs, but:
— the initial fault will be detected
during the EXPECTED SERVICE LIFE
of the ME EQUIPMENT and before a
second means for reducing a RISK
fails (e.g., suspended masses with
MECHANICAL PROTECTIVE
DEVICES); or
— the probability that the second
means of reducing the RISK will fail
of the ME EQUIPMENT is negligible.
Where a SINGLE FAULT CONDITION
causes another SINGLE FAULT
CONDITION, the two failures are
considered as one SINGLE FAULT
CONDITION.
During any test under SINGLE FAULT
CONDITION, only one fault at a time
shall be applied.
The results of the RISK ANALYSIS
shall be used to determine which
failures shall be tested. The failure of
any one component at a time that
could result in a HAZARDOUS
SITUATION, including those
to quality service
mentioned in 3.1, shall be simulated,

physically or theoretically. The
evaluation of whether a component is
subject to failure simulation shall take
into account the RISK associated with
the failure of the component during the
EXPECTED SERVICE LIFE of the ME
EQUIPMENT.
This evaluation shall be accomplished
by applying the principles of RISK
MANAGEMENT. The evaluation shall
take into account issues such as
reliability, TENSILE SAFETY
FACTORS, and rating of components.
Additionally, during the simulation of
SINGLE FAULT CONDITIONS,
component failures that are highly
probable or undetectable shall be
simulated.
Compliance is determined by applying

the specific requirements and tests
associated with the SINGLE FAULT
CONDITIONS identified in 13.2, and
tests for the failures identified from
evaluation of the results of the RISK
ANALYSIS. Compliance is confirmed if
the introduction of any of the SINGLE
FAULT CONDITIONS described in
13.2, one at a time, does not lead
directly to the HAZARDOUS
SITUATIONS described in 13.1, or any
other outcome that results in an
unacceptable RISK.
RMF (page, section)
to quality service

4.8 Component of ME EQUIPMENT All components, including wiring, the Components which could result in a NE
failure of which could result in a HAZARDOUS SITUATION should be
HAZARDOUS SITUATION shall be defined as an output of the hazard
used in accordance with their specified analysis (e.g.; FMEA), any
ratings unless a specific exception is HAZARDOUS SITUATIONS identified
made in this standard or through the should be mitigated according to the
RISK MANAGEMENT PROCESS. The Risk Management procedure and
reliability of components that are used documented in the RMF.
as MEANS OF PROTECTION shall be Additionally, the DHF should contain an
assessed for the conditions of use in assessment of any components which
the ME EQUIPMENT. They shall are used outside their ratings to
comply with one of the following (see determine if there are any additional
also 4.5): risks – if there are, these risks should
a) the applicable safety requirements be mitigated through application of the
of a relevant IEC or ISO standard; Risk Management Process.
b) where there is no relevant IEC/ISO
standard, the relevant ANSI standard Are specific exemptions made for any
shall be applied; if no relevant ANSI component of the device under
standard exists, the requirements of investigation to allow it to be used not in
this standard shall be applied. accordance with its specific rating?
See Figure 5 for a schematic flow
chart for (a) and (b). Are these exceptions formulated as the
Compliance is checked by inspection result of the risk management process?
and, where necessary, by test. The
tests of this standard for motors (see Have inspection or test requirements
13.2.8 and 13.2.13.3) and been formulated to make the hazardous
transformers (see 15.5.3) are situation acceptable?
considered to be comprehensive and
together with the evaluation of the
motor or transformer insulation system
according to Table 22 represent all
testing required by this standard. ME
SYSTEM components that provide
isolation from non-ME EQUIPMENT
are evaluated to clause 16.
RMF (page, section)
to quality service

4.9 HIGH INTEGRETY A COMPONENT WITH HIGH- This requirement applies only where a NE
COMPONENTS INTEGRITY CHARACTERISTICS single component is used to prevent a
shall be used when a fault in a SAFETY HAZARD as defined within the
particular component can generate an scope of this standard. The component
unacceptable RISK. COMPONENTS specification created as part of the
WITH HIGH-INTEGRITY design process should contain sufficient
CHARACTERISTICS shall be selected definition of the component to verify it
and evaluated consistent with their meets the requirements of a high
conditions of use and reasonably interity componnet. All high-integrity
foreseeable misuse during the components should be clearly identified
EXPECTED SERVICE LIFE of the ME in the DHF and tracable to the
EQUIPMENT. verification test report documenting
compliance with this standard.
of the RISK MANAGEMENT FILE and Are components with high-integrity
the selection criteria for the characteristics applied?
COMPONENTS WITH HIGH-
INTEGRITY CHARACTERISTICS. Have the risks associated with their use
been identified as such during the risk
assessment process, or in other words,
are they selected and evaluated
consistent with their conditions of use
and resonably foreseeable misuse
during the expected service life of the
equipment?
RMF (page, section)
to quality service


5.1 TYPE TESTS (General The tests described in this standard This is not a specific requirement, only NE
requirements for testing ME are TYPE TESTS. The tests to be clarification that the results of the
EQUIPMENT) performed are determined taking into HAZARD ANALYSIS should be used as
consideration the requirements of a reference when evaluating
clause 4, in particular 4.2. compliance with this standard.
A test need not be performed if Additionally, the results of testing
analysis shows that the condition against this standard should be
being tested has been adequately reviewed to determine if the HAZARD
evaluated by other tests or methods. ANALYSIS needs to be updated.
The results of the RISK ANALYSIS are
used to determine which For the selection of tests to be
combination(s) of simultaneous faults performed, is a risk management
are to be tested. process according to ISO 14971
applied?
For the determination of which

combination(s) of simultaneous faults
have to be tested, is a risk assessment
applied?
RMF (page, section)

5.4a) Other conditions (General a) Unless otherwise specified in this The verification test report should NE
requirements for testing ME standard, ME EQUIPMENT is to be clearly document the conditions under
EQUIPMENT tested under the least favorable which the device was tested. These
working conditions as specified in the conditions should take into account the
instructions for use that are identified intended use of the device including the
during RISK ANALYSIS. worst case use case(s) and
to quality service
environments.
For the testing of the equipment, have

the least favourable working conditions
been identified via the risk analysis?
RMF (page, section)

5.7 Humidity preconditioning Prior to the tests of 8.7.4 and 8.8.3, all The environment for use should be NE
treatment ME EQUIPMENT or its parts shall be specified in the DHF. If the
subjected to a humidity preconditioning enviornment for use can exceed the
treatment. general limits refered to here, the
ME EQUIPMENT or its parts shall be verification test plan/report should
set up complete (or where necessary clearly define the conditions that the
partially). Covers used during transport product was evaluated under to confirm
and storage are detached. safe operation under the intended use
This treatment is applied only to those environment.
ME EQUIPMENT parts which are
influenced by the climatic conditions Has it been determined via the
that are simulated by the test. application of the risk management
Parts that can be detached without the process whether the equipment can be
use of a TOOL are detached but are exposed to high humidity for extended
treated simultaneously with the major periods?
part.
ACCESS COVERS that can be NOTE: this is intended to ask if it is
opened or detached without the use of possible or likely the equipment will be
a TOOL are opened and detached. exposed to high humidity for extended
The humidity preconditioning treatment periods of time based on the intended
is performed in a humidity cabinet use/application of the equipment.
containing air with a relative humidity
of 93 % ± 3 %. The temperature of the Has the period for testing been
air in the cabinet, at all places where extended appropriately following the
ME EQUIPMENT can be located, is conclusions of the risk management
maintained within 2 C of any process?
convenient value T in the range of +
to quality service
20 C to + 32 C. Before being placed

in the humidity cabinet, ME
EQUIPMENT shall be brought to a
temperature between T and T + 4 C,
and kept at this temperature for at
least 4 h before the humidity
treatment.
ME EQUIPMENT and its parts is kept
in the humidity cabinet for 48 h.
Where the RISK MANAGEMENT
PROCESS suggests that the ME
EQUIPMENT can be exposed to high
humidity for extended periods (such as
ME EQUIPMENT intended for out-door
use), the period is extended
appropriately.
After the treatment, the ME
EQUIPMENT is reassembled, if
necessary.
RMF (page, section)

5.9.2.3 Actuating mechanisms Conductive parts of actuating The design requirements for these parts NA
mechanisms of electrical controls that should consider the need to remain
are accessible after the removal of attached over the EXPECTED
handles, knobs, levers, and the like SERVICE LIFE. This design
are regarded as ACCESSIBLE documentation should be reviewed to
PARTS. Conductive parts of actuating show compliance with this requirement.
mechanisms are not considered If the HAZARD ANALYSIS shows any
ACCESSIBLE PARTS if removal of concerns related to their detachment
to quality service
handles, knobs, etc. requires the use there will be data in the RMF –
of a TOOL and inspection of the RISK otherwise the DHF should contain the
MANAGEMENT FILE demonstrates information requested here.
that the relevant part is unlikely to
become detached unintentionally Has the result of the risk analysis
during the EXPECTED SERVICE LIFE demonstrated that the relevant part is
of the ME EQUIPMENT. See also unlikely to become attached
15.4.6.1. unintentionally during the expected
service life of the equipment and that an
acceptable residual risk results?
RMF (page, section)

7.1.1 USABILITY of the The MANUFACTURER shall address The USABILITY ENGINEERING FILE is NE
identification, marking, and in a USABILITY ENGINEERING a subset of documents generated
documents PROCESS the RISK of poor during the Usability Engineering
USABILITY associated with the design Process.
of the ME EQUIPMENT’S
identification, marking, and
documents. See IEC 60601-1-6 and
also see 1.3 and 12.2.

of the results of the USABILITY
ENGINEERING PROCESS.
RMF (page, section)
to quality service

7.2.2 Identification (Marking on theME EQUIPMENT and its detachable The labeling should be developed with NE
outside of ME EQUIPMENT or ME components shall be marked with the this requirement taken into account.
EQUIPMENT parts) name or trademark of the If there is an assessment relating to the
MANUFACTURER, and with a risk of misidentification it should be
MODEL OR TYPE REFERENCE included in the RMF.
unless misidentification does not
present an unacceptable RISK. Has it been determined that there is no
Software that forms part of a PEMS unacceptable risk resulting from
shall be identified with a unique equipment and detachable parts not
identifier, such as revision level or date being marked with the name or
of release/issue. The identification trademark of the manufacturer along
shall be available to designated with a model or type reference?
persons, e.g., SERVICE
PERSONNEL. The identification does
not need to be on the outside of the
ME EQUIPMENT.
RMF (page, section)

7.2.5 ME EQUIPMENT intended to If ME EQUIPMENT is intended to The labeling should be developed with NA
receive power from other equipment receive its power from other equipment this requirement taken into account.
(Marking on the outside of ME including ME EQUIPMENT in an ME If there is an assessment relating to the
EQUIPMENT or ME EQUIPMENT SYSTEM and connection to another risk of misidentification it should be
parts) source could result in an unacceptable included in the RMF.
RISK, the MODEL OR TYPE
REFERENCE of the specified other Are the model or type reference of the
equipment shall be marked adjacent to specified other equipment marked if this
the relevant connection point. See also could result in an unacceptable risk?
7.9.2.3, 8.2.1, and 16.3.
to quality service
RMF (page, section)


7.2.13 Physiological effects (safety ME EQUIPMENT producing The labeling should be developed with NA
signs and warning symbols) physiological effects that are not this requirement taken into account –
obvious to the OPERATOR and can including the use of the appropriate
cause HARM to the PATIENT or safety sign.
OPERATOR shall bear a suitable Hazards related to physiological effects
safety sign (see 7.5). The safety sign should be included in the RMF – there
shall appear in a prominent location so is no requirement for these to be
that it will be CLEARLY LEGIBLE in reviewed as part of this clause.
NORMAL USE after the ME
EQUIPMENT has been PROPERLY Do the instructions for the use describe
INSTALLED. the nature of the hazard and the
The instructions for use shall describe precautions for avoiding it or minimizing
the nature of the HAZARD and the the associated risk?
precautions for avoiding it or
minimizing the associated RISK.
RMF (page, section)

7.2.17 Protective packaging If special handling measures have to The labeling should be developed with NA
be taken during transport or storage, this requirement taken into account.
the packaging shall be marked
accordingly (see ISO 780). Can premature unpacking of equipment
to quality service
The permissible environmental or its parts result in an unacceptable

conditions for transport and storage risk?
shall be marked on the outside of the
packaging (see 7.9.3.1 and ISO Is the packaging marked with a suitable
15223). safety sign?
Where premature unpacking of ME
EQUIPMENT or its parts could result
in an unacceptable RISK, the
packaging shall be marked with a
suitable safety sign (see 7.5).
RMF (page, section)

7.3.3 Batteries The type of battery and the mode of Devices with batteries should be NE
insertion (if applicable) shall be designed and labeled taking this
marked (see 15.4.3.2). requirement into account.
For batteries intended to be changed Any HAZARDs identified (as referenced
only by SERVICE PERSONNEL with in this requirement) must be disclosed
the use of a TOOL, an identifying in the instructions for use
marking referring to information stated (ACCOMPANYING DOCUMENTS).
in the ACCOMPANYING General RISKS associated with the use
DOCUMENTS is sufficient. of batteries should be included in the
Where lithium batteries or fuel cells are RMF. There is no requirement to
incorporated and where incorrect review the RMF as part of this clause.
replacement would result in an
unacceptable RISK, a warning Are there lithium batteries or fuel cells
indicating that replacement by which are incorporated where incorrect
inadequately trained personnel could replacement could result in an
result in a HAZARD (such as unacceptable risk?
excessive temperatures, fire, or
explosion) shall be given in addition to Is there a warning indicating that
the identifying marking referring to replacement by inadequately trained
to quality service
information stated in the personnel could result in a hazard?

ACCOMPANYING DOCUMENTS.
RMF (page, section)

7.3.7 Supply Terminals Terminals for supply conductors shall Supply terminals must be marked with NA
be marked adjacent to the terminals their connection points unless it can be
unless it can be demonstrated that no shown that there is no hazard resulting
HAZARDOUS SITUATION can result if from miss connection.
connections are interchanged.
Are terminals for supply conductors
If ME EQUIPMENT is so small that the marked adjacent to the terminals?
terminal marking cannot be affixed,
they shall be included in the Does the identification of known or
ACCOMPANYING foreseeable hazards (risk management
DOCUMENTS. file) demonstrate that no hazardous
situation can result if connections are
Terminals that are provided exclusively interchanged?
for the connection of the neutral supply
conductor in PERMANENTLY
INSTALLED ME
EQUIPMENT shall be marked with the
appropriate code from IEC 60445 (see
Table D.3, Code 1).
If marking for connection to a three-

phase supply is necessary, it shall be
according to IEC 60445.
Markings that are on or adjacent to
electrical connection points shall not
be affixed to parts that have to be
removed
to make the connection. They shall
to quality service
remain visible after the connection has

been made.
RMF (page, section)

7.4.2 Control devices Different positions of control devices The design of the control devices NE
and different positions of switches on should be done taking this requirement
ME EQUIPMENT shall be indicated by into account.
figures, letters, or other visual means, Additionally, application of a Usability
e.g., by use of symbols IEC 60417- Engineering Process should result in
5264 (DB:2002-10) and IEC 60417- the information required here being
5265 (DB:2002- 10) (see Table D.1, developed and recorded in the DHF.
symbols 16 and 17).
If in NORMAL USE the change of In normal use, can the change of setting
setting of a control could result in an of a control result in an unacceptable
unacceptable RISK to the PATIENT, risk to the patient?
such controls shall be provided with
either: Review the manufacturers risk
— an associated indicating device, management file for risk analysis, risk
e.g., instruments or scale, or evaluation and where necessary
— an indication of the direction in implementation of risk control.
which the magnitude of the function
changes. See also 15.4.6.2.
RMF (page, section)

to quality service
7.5 Safety signs For the purpose of this clause, During the design of labeling – NE
markings used to convey a warning, specifically labeling used as a RISK
prohibition, or mandatory action that MITIGATION, there must be an
mitigates a RISK that is not obvious to assessment to determine if the item
the OPERATOR shall be a safety sign being mitigated is obvious to the
selected from ISO 7010. OPERATOR. If it is, then a symbol is
Where a safety sign is not available to acceptable; if not then a safety sign is
indicate a particular desired meaning, required.
the meaning may be obtained by one Evidence of the RISKS mitigated
of the following methods. through the use of labeling should be
a) Constructing a safety sign according noted in the RMFile – a smaller subset
to ISO 3864-1:2002, clause 7 (for the of these where the mitigation is a
corresponding templates, see Table symbol require this additional
D.2, safety signs 1, 4, and 8). assessment.
b) Using the general warning sign ISO The DHF should contain the labeling
7010:2003-W001 (see Table D.2, requirements (design).
safety sign 2) placed together with a
supplementary symbol or text. The text Is marking used to convey a warning,
associated with the general warning prohibition or mandatory action that
sign shall be an affirmative statement mitigates a risk that is not obvious to the
(i.e., a safety notice) describing the operator?
principal RISK(S) foreseen (e.g.,
“Causes burns”, “RISK of explosion”, Review the manufacturers risk
etc.). management file for risk analysis, risk
c) Using the general prohibition sign evaluation and where necessary,
ISO 7010:2003-P001 (see Table D.2, implementation of risk control.
safety sign 4) placed together with a
supplementary symbol or text. The text
associated with the general prohibition
sign shall be a statement (i.e., a safety
notice) describing what is prohibited
(e.g., “Do not open”, “Do not drop”,
etc.).
d) Using the general mandatory action
sign ISO 7010:2003-M001 (see Table
D.2, safety sign 8) placed together with
a supplementary symbol or text. The
text associated with the general
mandatory action sign shall be a
command (i.e., a safety notice)
describing required action (e.g., “Wear
protective gloves”, “Scrub before
entering”, etc.).
to quality service
If there is insufficient space to place

the affirmative statement together with
the safety sign on the ME
EQUIPMENT, it may be placed in the
instructions for use.
Safety signs, including any
supplementary symbol or text, shall be
explained in the instructions for use
(see 7.9.2).
Compliance is checked by inspection.
RMF (page, section)

7.9.1 General (ACCOMPANYING ME EQUIPMENT shall be The RISK aspect of this requirement NE
DOCUMENTS) accompanied by documents containing only applies when the
at least the instructions for use and a ACCOMPANYING DOCUMENTS are
technical description. The provided electronically and not in hard
ACCOMPANYING DOCUMENTS shall copy.
be regarded as a part of the ME If this is the case, there should be a
EQUIPMENT. review to determine if any minimal
The ACCOMPANYING DOCUMENTS information should be provided in hard
shall identify the ME EQUIPMENT by copy – this requirement also exists in
including, as applicable, the following: IEC 60601-1-6:2006 and IEC
— Name or trade name of the 62366:2007.
MANUFACTURER, and an address to Justification for the use of electronic-
which the RESPONSIBLE only instructions should be based on
ORGANIZATION can refer; the intended use, use environment, and
— MODEL OR TYPE REFERENCE OPERATOR PROFILE as well as any
(see 7.2.2). specific risks associated with the
ACCOMPANYING DOCUMENTS may OPERATOR/RESPONSIBLE
be provided electronically, e.g., ORGANIZATION failing to follow the
electronic file format on CD-ROM. If instructions.
the ACCOMPANYING DOCUMENTS
to quality service
are provided electronically, the RISK Has the manufacturer applied the risk
MANAGEMENT PROCESS shall management process to determine
include consideration of which which information also needs to be
information also needs to be provided provided as hard copy or as marking on
as hard copy or as markings on the the equipment?
ME EQUIPMENT, e.g., to cover
emergency operation.
The ACCOMPANYING DOCUMENTS
shall specify any special skills, training,
and knowledge required of the
intended OPERATOR or the
RESPONSIBLE ORGANIZATION and
any restrictions on locations or
environments in which the ME
EQUIPMENT can be used.
The ACCOMPANYING DOCUMENTS
shall be written at a level consistent
with the education, training, and any
special needs of the person(s) for
whom they are intended.
RMF (page, section)

7.9.2.2 Warning and safety notices The instructions for use shall include The labeling should be developed with NE
all warning and safety notices. this requirement taken into account.
For CLASS I ME EQUIPMENT, the
instructions for use shall include a
warning statement to the effect:
“WARNING: To avoid the RISK of
electric shock, this equipment must
only be connected to a SUPPLY
to quality service
MAINS with protective earth.”

The instructions for use shall provide
the OPERATOR or RESPONSIBLE
ORGANIZATION with warnings
regarding any significant RISKS of
reciprocal interference posed by the
presence of the ME EQUIPMENT
during specific investigations or
treatments.
The instructions for use shall include
information regarding potential
electromagnetic or other interference
between the ME EQUIPMENT and
other devices together with advice on
ways to avoid or minimize such
interference.
If the ME EQUIPMENT is provided
with an integral MULTIPLE SOCKET-
OUTLET, the instructions for use shall
provide a warning statement that
connecting electrical equipment to the
MSO effectively leads to creating an
ME SYSTEM and the result can be a
reduced level of safety. For the
requirements that are applicable to an
ME SYSTEM, the RESPONSIBLE
ORGANIZATION shall be referred to
this standard.
RMF (page, section)

7.9.2.4 Electrical power sources For mains-operated ME EQUIPMENT Devices with batteries (or other non- NE
with an additional power source not MAINS supplies) should be designed
automatically maintained in a fully and labeled taking this requirement into
usable condition, the instructions for account.
use shall include a warning statement Any HAZARDs identified (as referenced
referring to the necessity for periodic in this requirement) must be disclosed
checking or replacement of such an in the instructions for use
additional power source. (ACCOMPANYING DOCUMENTS).
to quality service
If leakage from a battery would result General RISKS associated with the use
in an unacceptable RISK, the of batteries should be included in the
instructions for use shall include a RMF. There is no requirement to
warning to remove the battery if the review the RMF as part of this clause.
ME EQUIPMENT is not likely to be
used for some time. If leakage from a battery would result in
If an INTERNAL ELECTRICAL an unacceptable risk, do the
POWER SOURCE is replaceable, the instructions for use include a warning to
instructions for use shall state its remove the battery if the equipment is
specification. not likely to be used for some time?
If loss of the power source would result
in an unacceptable RISK, the Review the manufacturers risk
instructions for use shall contain a management file for risk analysis, risk
warning that the ME EQUIPMENT evaluation and where necessary,
must be connected to an appropriate implementation of risk control.
power source.
If loss of power would result in an
unacceptable risk, do the instructions
for use include a warning that the
equipment must be connected to an
appropriate power source?
Review the manufacturers risk

management file for risk analysis, risk
evaluation, and where necessary,
implementation of risk control.
RMF (page, section)

7.9.2.5 ME EQUIPMENT description The instructions for use shall include: The instructions for use should be NE
— a brief description of the ME developed taking this requirement into
EQUIPMENT; account.
— how the ME EQUIPMENT
to quality service
functions; and Do the instructions for use include

— the significant physical and information on the materials or
performance characteristics of the ME ingredients to which the patient or
EQUIPMENT. operator is exposed if such exposure
If applicable, this description shall can constitute an unacceptable risk?
include the expected positions of the
OPERATOR, PATIENT, and other Review the manufacturers risk
persons near the ME EQUIPMENT in management file for risk analysis, risk
NORMAL USE (see 9.2.2.3). evaluation and if necessary,
The instructions for use shall include implementation of risk control.
information on the materials or
ingredients to which the PATIENT or
OPERATOR is exposed if such
exposure can constitute an
unacceptable RISK (see 11.7).
The instructions for use shall specify
any restrictions on other equipment or
NETWORK/DATA COUPLINGS, other
than those forming part of an ME
SYSTEM, to which a SIGNAL
INPUT/OUTPUT PART may be
connected.
The instructions for use shall indicate
any APPLIED PART.
RMF (page, section)

7.9.2.15 Environmental protection The instructions for use shall: The instructions for use should be NE
— identify any RISKS associated with developed taking this requirement into
the disposal of waste products, account
residues, etc., and of the ME
EQUIPMENT and ACCESSORIES at
the end of their EXPECTED SERVICE
LIFE; and
— provide advice on minimizing these
RISKS.
to quality service
RMF (page, section)

7.9.3.2 Replacement of fuses, The technical description shall contain, The technical description should be NE
POWR SUPPLY CORDS, and other as applicable, the following: developed taking this requirement into
parts — the required type and full rating of account.
fuses used in the SUPPLY MAINS
external to PERMANENTLY Where replacement of a component
INSTALLED ME EQUIPMENT, if the could result in an unacceptable risk, is
type and rating of these fuses are not there appropriate warnings to identify
apparent from the information the nature of the hazard and, if the
concerning RATED current and mode manufacturer specifies the component
of operation of ME EQUIPMENT; as replaceable by service personnel, is
— for ME EQUIPMENT having a non- all information necessary to safely
DETACHABLE POWER SUPPLY replace the component?
CORD, a statement as to whether the
POWER SUPPLY CORD is Review the manufacturers risk
replaceable by SERVICE management file for risk analysis, risk
PERSONNEL, and if so, instructions evaluation and if necessary, risk control
for correct connection and anchoring measures.
to ensure that the requirements of
8.11.3 will continue to be met;
— instructions for correct replacement
of interchangeable or detachable parts
that the MANUFACTURER specifies
as replaceable by SERVICE
PERSONNEL; and
— where replacement of a component
could result in an unacceptable RISK,
appropriate warnings that identify the
nature of the HAZARD and, if the
MANUFACTURER specifies the
component as replaceable by
SERVICE PERSONNEL, all
information necessary to safely
replace the component.
RMF (page, section)
to quality service


8.1 b) SINGLE FAULT CONDITION — interruption of any one power- This requirement only applies to parts NE
includes: carrying conductor between ME where there are power carrying
(6th Dash) EQUIPMENT parts in separate conductors running between separate
ENCLOSURES, if the RISK parts of the ME EQUIPMENT (parts
ANALYSIS indicates that this condition with separate enclosures).
might cause permitted limits to be The design should be reviewed to
exceeded; determine if fault testing on these
conductors should be conducted – if it is
determined that fault testing is required,
the results should be reviewed to
determine if the construction is in
compliance with the requirements of
this standard.
Has the manufacturer identified in their

risk analysis if the interruption of any
one power carrying conductor between
equipment parts in separate enclosures
might cause permitted limits (voltage,
current, energy) to be exceeded?
During the product safety verification,

this must be one of the SFC's tested.
RMF (page, section)
to quality service

8.1 b) SINGLE FAULT CONDITION — unintended movement of a This requirement only applies to parts NE
includes: component; but only if the component where there are power carrying
(7th Dash) is not mounted securely enough to conductors running between separate
ensure that such movement will be parts of the ME EQUIPMENT (parts
very unlikely to occur during the with separate enclosures).
EXPECTED SERVICE LIFE of the ME The design should be reviewed to
EQUIPMENT, as determined by the determine if fault testing on these
RISK MANAGEMENT PROCESS (see conductors should be conducted – if it is
also 8.10.1); determined that fault testing is required,
this standard.
Has the manufacturer identified in their

risk management process that a
component's movement must be
considered as a SFC because of its
lack of securement (8.10.1) over the
expected service life of the equipment
may cause permitted limits (voltage,
current, energy) to be exceeded?
During the product safety verification,

this must be one of the SFC's tested.
RMF (page, section)

8.1 b) SINGLE FAULT CONDITION — accidental detachment of This requirement only applies to parts NA
to quality service
includes: conductors and connectors where where there are power carrying
(8th Dash) breaking free could lead to a conductors running between separate
HAZARDOUS SITUATION. See also parts of the ME EQUIPMENT (parts
8.10.2. with separate enclosures).
The design should be reviewed to
determine if fault testing on these
conductors should be conducted – if it is
determined that fault testing is required,
this standard.
RMF (page, section)

8.2.2 Connection to an external d.c. If ME EQUIPMENT is specified for The design should take this requirement NA
power source power supplied from an external d.c. into account during design inputs – the
power source, no HAZARDOUS verification of compliance is performed
SITUATION, other than absence of as needed by disconnecting the supply
ESSENTIAL PERFORMANCE, shall and verifying nothing other than loss of
develop when a connection with the power happens.
wrong polarity is made. The ME
EQUIPMENT, when connection is Does equipment specified for power
subsequently made with the correct supplied from an external dc power
polarity, shall provide freedom from source, have no hazardous situation,
unacceptable RISK. Protective devices other than the absence of essential
that can be reset by anyone without performance, develop when connection
the use of a TOOL are acceptable with the wrong polarity is made?
provided that these restore correct
operation on reset. Review the manufacturers risk
management file for risk analysis and
Compliance is checked by inspection risk evaluation.
and, if necessary, by functional tests.
Does the equipment, when connection
is subsequently made with the correct
polarity, provide freedom from
unacceptable risk?
to quality service

management file for risk analysis and
risk evaluation.
RMF (page, section)

8.3 d) Classification of APPLIED d) * For a part that is identified See 4.6. NE
PARTS according to 4.6 as needing to be
subject to the requirements for an Has the manufacturer identified in their
APPLIED PART (except for marking), risk management process the need for
the requirements for a TYPE B parts (not being applied parts) to be
APPLIED PART shall apply unless the subject to the requirements for an
RISK MANAGEMENT PROCESS applied part of type BF or CF?
identifies a need for the requirements
for a TYPE BF APPLIED PART or Ensure during the product safety
TYPE CF APPLIED PART to apply. verification these parts are tested
accordingly.
RMF (page, section)

8.4.2.c ) ACCESSIBLE PARTS c) * The limits specified in (b) above do This requirement should be satisfied NE
including APPLIED PARTS not apply to the following parts if the through review of the instructions for
probability of a connection to a use and the intended use of the
PATIENT, either directly or through the equipment.
body of the OPERATOR, through Any parts following this exemption
which a current exceeding the should be identified as part of the
allowable TOUCH CURRENT could verification test based on the guidance
flow, is negligible in NORMAL USE, for exemption included in this clause.
to quality service
and the instructions for use instruct the

OPERATOR not to touch the relevant Has the manufacturer identified parts
part and the PATIENT simultaneously: (not being applied parts) where current
— accessible contacts of connectors; exceeding the allowable touch current
— contacts of fuseholders that are could flow, either directly or through the
accessible during replacement of the body of the operator, however, the risk
fuse; analysis determined that the probability
— contacts of lampholders that are in normal use is negligible?
accessible after removal of the lamp;
— parts inside an ACCESS COVER During the product safety verification,
that can be opened without the use of these identified parts do not require
a TOOL, or where a TOOL is needed touch current testing.
but the instructions for use instruct any
OPERATOR other than SERVICE Verify the instructions for use include
PERSONNEL to open the relevant instructions for the operator not to touch
ACCESS COVER. the relevant part and the patient
simultaneously.
For such parts, the voltage to earth or
to other ACCESSIBLE PARTS shall
not exceed 42.4 V peak a.c. or 60 V
d.c. in NORMAL CONDITION or in
SINGLE FAULT CONDITION. The d.c.
limit of 60 V applies to d.c. with not
more than 10 % peak-to-peak ripple. If
the ripple exceeds that amount, the
42.4 V peak limit applies. The energy
shall not exceed 240 VA for longer
than 60 s or the stored energy
available shall not exceed 20 J at a
potential up to 2 V.

of the RISK MANAGEMENT FILE, by
reference to the instructions for use
and by measurement.
RMF (page, section)
to quality service

8.5.1.1 General (MEANS OF ME EQUIPMENT shall have two This requirement only points out that NE
PROTECTION) MEANS OF PROTECTION to prevent considerations of coatings and other
APPLIED PARTS and other insulation complying with IEC 60950-1
ACCESSIBLE PARTS from exceeding is suitable for protection of the
the limits specified in 8.4. OPERATOR but not the PATIENT.
Each MEANS OF PROTECTION shall
be categorized as a MEANS OF
PATIENT PROTECTION or a MEANS
OF OPERATOR PROTECTION,
taking account of 4.6. See also Figure
A.12.
Varnishing, enamelling, oxidation, and
similar protective finishes, as well as
covering with sealing compounds that
can replasticize at temperatures to be
expected during operation (including
sterilization), shall not be regarded as
a MEANS OF PROTECTION.
Components and wiring forming a

MEANS OF PROTECTION shall
comply with the relevant requirements
of 8.10.
Any insulation, CREEPAGE
DISTANCE, AIR CLEARANCES,
component, or earth connection that
does not comply with the requirements
of 8.5.1.2 and 8.5.1.3 shall not be
considered as a MEANS OF
PROTECTION. Failure of any or all
such parts shall be regarded as
NORMAL CONDITION.
RMF (page, section)

8.5.2.2 TYPE B APPLIED PARTS The PATIENT CONNECTION(s) of a The requirement related to risk is the NE
to quality service
TYPE B APPLIED PART that is not 2nd bullet. The construction of the
PROTECTIVELY EARTHED shall be device (APPLIED PART and
separated by one MEANS OF ACCESSIBLE PART) should be
PATIENT PROTECTION from metal reviewed to determine if it is likely that
ACCESSIBLE PARTS that are not the ACCESSIBLE PART will contact
PROTECTIVELY EARTHED, unless: source voltages – this should be
— the metal ACCESSIBLE PART is documented in the DHF.
physically contiguous with the If the connection is possible, then the
APPLIED PART and can be regarded MOP shall be maintained in accordance
as a part of the APPLIED PART; and with this requirement.
— the RISK that the metal
ACCESSIBLE PART will make contact Has the manufacturer identified in the
with a source of voltage or LEAKAGE risk management file, unearthed type B
CURRENT above permitted limits is applied parts that are not separated
acceptably low. from unearthed conductive accessible
parts, however, determined that the
Compliance is checked by inspection, level of risk that the unearthed
by the LEAKAGE CURRENT tests of accessible part will make contact with a
8.7.4, by the dielectric strength test of source voltage or leakage current
8.8.3, by measurement of relevant above the permitted limits is acceptably
CREEPAGE DISTANCES and AIR low.
CLEARANCES, and by reference to
the RISK MANAGEMENT FILE. If yes, accepted.
If no, one means of protection is

required.
RMF (page, section)

8.5.2.3 PATIENT leads Any connector for electrical This requirement does not make NA
connections on a PATIENT lead that: specific reference to the RMF, however
— is at the end of the lead remote it does require an assessment with the
from the PATIENT; and unjointed test finger unless the RISK
— contains a conductive part that is MANAGEMENT PROCESS shows
not separated from all PATIENT there is no risk.
to quality service
CONNECTION(S) by one MEANS OF This assessment should be made as

PATIENT PROTECTION for a part of the design if the unjointed test
WORKING VOLTAGE equal to the finger can make contact the design
MAXIMUM MAINS VOLTAGE should be reviewed to determine if it is
shall be constructed so that the said acceptable. If the exception will be
part cannot become connected to utilized, then the RMF should contain a
earth or possible hazardous voltage pointer to the assessment.
while the PATIENT CONNECTION(S)
contact the PATIENT. Has the manufacturer identified in their
In particular: risk management process connectors
— the said part shall not come into for electrical connections on a patient
contact with a flat conductive plate of lead at the end of the lead remote from
not less than 100 mm diameter; the patient that contains a conductive
— the AIR CLEARANCE between part that is not separated from all
connector pins and a flat surface shall patient connections by one MOPP for a
be at least 0.5 mm; working voltage equal to the maximum
— if able to be plugged into a mains mains voltage, that will not present an
socket, the said part shall be protected unacceptable risk from contact with
from making contact with parts at objects other than a mains socket outlet
MAINS VOLTAGE by insulating means or a flat surface (e.g. corners or
providing a CREEPAGE DISTANCE of edges)?
at least 1.0 mm and a dielectric
strength of 1,500 V and complying with During the product safety verification,
8.8.4.1; the test using a straight, un-jointed test
— the straight unjointed test finger with finger with a force of 10 N is not
the same dimensions as the standard required, however, the remaining
test finger of Figure 6 shall not make inspections of this clause are required.
electrical contact with the said part if
applied in the least favorable position
against the access openings with a
force of 10 N, unless the RISK
MANAGEMENT PROCESS
demonstrates that no unacceptable
RISK exists from contact with objects
other than a mains socket or a flat
surface (e.g., corners or edges).
and test as required.
RMF (page, section)
to quality service


8.6.3 protective earthing of moving Any PROTECTIVE EARTH The information required here should be NA
parts CONNECTION shall not be used for a part of the DHF – there should not be a
moving part unless the need to assess this requirement
MANUFACTURER demonstrates that through the application of the RISK
the connection will remain reliable MANAGEMENT PROCESS.
of the ME EQUIPMENT. Does the manufacturer's risk
management file indicate the need to
Compliance is checked by inspection bond moving parts to the protective
of the ME EQUIPMENT and, if earth connection?
necessary, inspection of the RISK
MANAGEMENT FILE. Has the manufacturer demonstrated the
reliability of the connection during the
expected service life?
RMF (page, section)

8.6.7 POTENTIAL EQUALIZATION If ME EQUIPMENT is provided with a There is no specific reference to the NE
CONDUCTOR terminal for the connection of a RMF here. The 2nd bullet addresses
POTENTIAL EQUALIZATION RISK.
CONDUCTOR, the following If these connections are provided the
requirements apply. design should minimize the risk of
— The terminal shall be accessible to accidental disconnection. Evidence
to quality service
the OPERATOR with the ME should be located in the DHF.

EQUIPMENT in any position of
NORMAL USE.
— The RISK of accidental
disconnection shall be minimized in
NORMAL USE.
— The terminal shall allow the
conductor to be detached without the
use of a TOOL.
— The terminal shall not be used for a
PROTECTIVE EARTH
CONNECTION.
— The terminal shall be marked with
symbol IEC 60417-5021 (DB:2002-10)
(see Table D.1, symbol 8).
— The instructions for use shall
contain information on the function and
use of the POTENTIAL
EQUALIZATION CONDUCTOR
together with a reference to the
requirements of this standard for ME
SYSTEMS.
The POWER SUPPLY CORD shall not
incorporate a POTENTIAL
EQUALIZATION CONDUCTOR.

RMF (page, section)

8.8.4.1 Mechanical strength and The resistance to heat shall be The design data for insulation should be NE
resistance to heat (Insulation other retained by all types of insulation, contained within the DHF (the
than wire insulation) including insulating partition walls, EXPECTED SERVICE LIFE should also
during the EXPECTED SERVICE LIFE be included in the DHF).
of the ME EQUIPMENT.
Compliance is checked by inspection Has the manufacturer identified in the
of the ME EQUIPMENT and the RISK risk management file the need for
MANAGEMENT FILE and, if insulation of all types, considering its
necessary, in conjunction with the resistance to heat in the application and
to quality service
following tests: the expected service life?

— resistance to moisture, etc. (see
11.6); Has the manufacturer identified any
— dielectric strength (see 8.8.3); specific test protocols that must be
— mechanical strength (see 15.3). performed during the product safety
Resistance to heat is established by verification?
the following tests, which need not be
performed if satisfactory evidence of Conduct the test required in this clause
compliance is provided. and any additional tests or inspections
a) For parts of the ENCLOSURE and identified in the risk management file.
other external insulating parts, the
deterioration of which could result in
an unacceptable RISK, by the ball-
pressure test:
ENCLOSURES and other external
parts of insulating material, except the
insulation of flexible cords and parts of
ceramic material, are subjected to a
ball-pressure test using the test
apparatus shown in Figure 21. The
surface of the part to be tested is
placed in the horizontal position and a
steel ball of 5 mm diameter is pressed
against the surface with a force of 20
N. The test is performed in a heating
cabinet at a temperature of 75 C ± 2
C or the ambient temperature
indicated in the technical description
(see 7.9.3.1) ± 2 C plus the
temperature rise of the relevant part of
insulating material measured during
the test of 11.1, whichever is the
higher.
The ball is withdrawn after 1 h and the
diameter of the impression made by
the ball is measured. An impression
greater than 2 mm in diameter
constitutes a failure.
b) For parts of insulating material that
support uninsulated parts of the
MAINS PART, the deterioration of
which could influence the safety of the
ME EQUIPMENT, by the ball-pressure
to quality service
test:
A test is performed as described in (a)
above, but at a temperature of 125 C
± 2 C or at the ambient temperature
indicated in the technical description
(see 7.9.3.1) ± 2 C plus the
temperature rise that was determined
during the test of 11.1 of the relevant
part, whichever is the higher.
The test is not performed on parts of
ceramic material, insulating parts of
commutators, brush-caps, and the like,
and on coil formers not used as
REINFORCED INSULATION.
NOTE—For SUPPLEMENTARY
INSULATION and REINFORCED
INSULATION of thermoplastic
materials, see also 13.1.2.
RMF (page, section)

8.10.1 Fixing of components Components of ME EQUIPMENT, the Information on the fixing of components NE
(Components and wiring) unwanted movement of which could should be included in the DHF.
result in an unacceptable RISK, shall Specific risks associated with
be mounted securely to prevent such components may be included in the
movement. RMF where a specific hazard exists
(identified during the HAZARD
Compliance is checked by inspection ANALYSIS).
of the ME EQUIPMENT and the RISK
MANAGEMENT FILE. Has the manufacturer identified
to quality service
components the movement of which

could result in an unacceptable risk in
their risk management file?
Verify that such components are

securely mounted and will remain so for
the expected service life.
RMF (page, section)

8.10.2 Fixing of wiring (Components Conductors and connectors of ME Information on the fixing of conductors NE
and wiring) EQUIPMENT shall be so secured or and connectors should be included in
insulated that accidental detachment the DHF.
shall not result in a HAZARDOUS Specific risks associated with
SITUATION. They are not considered components may be included in the
to be adequately secured if on Risk Management File where a specific
breaking free at their joint and moving hazard exists (identified during the
about their support point they are HAZARD ANALYSIS)
capable of touching circuit points (NOTE: the term HAZARDOUS
resulting in a HAZARDOUS SITUATION is misused here, the
SITUATION. correct term should be
Breaking free of one means of UNACCEPTABLE RISK).
mechanical restraint shall be
considered a SINGLE FAULT Has the manufacturer identified in their
CONDITION. risk management file the need to
Stranded conductors shall not be restrain by double securement any
solder-coated if they are affixed by any conductors and connectors where if
clamping means and poor contact they were to break free and touch circuit
could result in a HAZARDOUS points this could result in a hazardous
SITUATION. situation?
to quality service
Compliance is checked by inspection Inspect the construction and restraint of

of the ME EQUIPMENT and the RISK these conductors and connections to
MANAGEMENT FILE. ensure that they are held in place by
use of double securement.
RMF (page, section)

8.10.5 Mechanical protection of a) Internal cables and wiring shall be Information on the fixing of conductors NE
wiring adequately protected against contact and connectors should be included in
with a moving part or from friction at the DHF.
sharp corners and edges where Specific risks associated with
damage to insulation could result in a components may be included in the
HAZARDOUS SITUATION. Risk Management File where a specific
b) ME EQUIPMENT shall be so hazard exists (identified during the
designed that wiring, cord forms, or HAZARD ANALYSIS)
components are not likely to be (NOTE: the term HAZARDOUS
damaged during assembly or the SITUATION is misused here, the
opening or closing of ACCESS correct term should be
COVERS where such damage could UNACCEPTABLE RISK).
result in a HAZARDOUS SITUATION.
Has the manufacturer identified in the
Compliance is checked by inspection risk management file the need to
and, where appropriate, by manual protect against contact with moving
test or reference to the RISK parts, friction at sharp corners and
MANAGEMENT FILE. edges, or damage during assembly or
the opening or closing of access covers
of internal cables, wiring, cord forms or
components, where the damage or
insulation damage could result in a
hazardous situation?
to quality service
Inspect these parts carefully

considering their location and potential
damage during assembly, disassembly,
contact with moving parts an friction at
sharp corners and edges.
RMF (page, section)

8.11.5 Mains fuses and OVER- A fuse or OVER-CURRENT RELEASE There are likely (2) situations where this NE
CURRENT RELEASES shall be provided in each supply lead requirement will apply:
for CLASS I ME EQUIPMENT and for 1. Devices in which the
CLASS II ME EQUIPMENT having a fuse/OVERCURRENT RELEASE is
functional earth connection according provided by the installer
to 8.6.9, and in at least one supply 2. Devices which do not have
lead for other singlephase CLASS II fuses/OVERCURRENT RELEASEs
ME EQUIPMENT, except that: provided
— for PERMANENTLY INSTALLED
ME EQUIPMENT, the neutral For (1) the installation instructions
conductor shall not be fused; should identify the appropriate
— if examination shows that two protective device to be included in the
MEANS OF PROTECTION are installation.
present between all parts of opposite For (2) the device should be tested
polarity within the MAINS PART, and according to this standard to determine
between all parts of the MAINS PART that it complies with all the
and earth, then the fuses or OVER- requirements. Satisfaction of these
CURRENT RELEASES may be requirements should be sufficient.
omitted. These insulation requirements
shall be continued up to and within any Has the manufacturer provided
component. The effect of shortcircuit justification for omission of the fuses or
fault conditions in other circuits shall over-current releases in the risk
to quality service
be considered before eliminating fuses management file?

or OVER-CURRENT RELEASES.
A PROTECTIVE EARTH Inspect the circuit according to the
CONDUCTOR shall not incorporate a requirements of this clause ensuring
fuse or OVER-CURRENT RELEASE. double insulation and acceptable fault
Protective devices shall have condition tests results.
adequate breaking capacity to interrupt
the maximum fault current (including
short-circuit current) which can flow.
Justification for omission of fuses or
OVER-CURRENT RELEASES shall
be included in the RISK
MANAGEMENT FILE.

MANAGEMENT FILE.
RMF (page, section)

9.2.1 General (HAZARDS ME EQUIPMENT with moving parts The DHF and RMF should contain the NE
associated with moving parts) shall be designed, built, and laid out so evidence required.
that, when PROPERLY INSTALLED
and used as indicated in the Are protective measures used to reduce
ACCOMPANYING DOCUMENTS or the risk from contact with moving parts?
under reasonably foreseeable misuse,
the RISKS associated with those Considering use as indicated in the
moving parts are reduced to an accompanying documents or
acceptable level. reasonably foreseeable misuse and
The RISK from contact with the bearing in mind the ease of access, the
moving parts shall be reduced to an equipment function, the shape of the
to quality service
acceptable level by use of protective parts, the energy and speed of motion
measures, bearing in mind the ease of and the benefits to the patient, is the
access, the ME EQUIPMENT’S risk reduced to an acceptable level?
function, the shape of the parts, the
energy and speed of the motion and Is exposure to moving parts needed for
the benefits to the PATIENT. equipment to perform its intended
The RESIDUAL RISK associated with function?
moving parts is considered acceptable
if exposure is needed for the ME Have all reasonable protective
EQUIPMENT to perform its intended measures including warning markings
function. If after all reasonable to the equipment where the hazards
protective measures have been persist been implemented?
implemented HAZARDS persist,
warnings shall be marked on the ME
EQUIPMENT or given in the
instructions for use.
RMF (page, section)

9.2.2.4.1 Access to TRAPPING A TRAPPING ZONE is considered not GUARDS are essentially mitigation of NE
ZONES to present a MECHANICAL HAZARD if existing RISKS.
GUARDS and protective measures: The Risk Management File and DHF
— are of robust construction; should contain the information required
— are not easy to bypass or render here.
non-operational; and
— do not introduce any additional
unacceptable RISK.
Compliance is checked by the
applicable tests of 15.3 for
ENCLOSURES.
to quality service

RMF (page, section)

9.2.2.4.3 Movable GUARDS Movable GUARDS that can be opened The design of the GUARDS should take NE
without the use of a TOOL: these requirements into account. There
— shall remain attached to the ME should not be any need for specific
EQUIPMENT when the GUARD is RAC items since the GUARDS are
open; already mitigations.
— shall be associated with an interlock
device that prevents the relevant The risks caused by mechanical
moving parts from starting to move hazards associated with moving parts
while the TRAPPING ZONE is and reduced by use of the movable
accessible and stops movement when guards are addressed?
the GUARD is opened; and
— shall be so designed that the
absence or failure of one of their
components prevents starting, and
stops moving parts.
Compliance is checked by conducting

any applicable tests and inspection of
the ME EQUIPMENT and the RISK
MANAGEMENT FILE.
RMF (page, section)
to quality service

9.2.2.4.4 Protective measures Protective measures shall be designed The mechanical system should be NE
and incorporated into the control design taking these requirements into
system so that: account. The information required here
— moving parts cannot start to move should be included in the DHF.
while they are in the reach of persons;
— once the ME EQUIPMENT has The risks caused by mechanical
started to move, the TRAPPING ZONE hazards associated with moving parts
cannot be reached, or, if the and reduced by the use of protective
TRAPPING ZONE is reached, system measures incorporated in the control
movement must stop (in the later case, system are addressed?
no HAZARD or damage shall result);
and
— if in a SINGLE FAULT CONDITION
of the protective measure, an
unacceptable RISK could arise, one or
more emergency stopping device(s) in
the ME EQUIPMENT shall be provided
(see 9.2.4).

MANAGEMENT FILE.
RMF (page, section)

9.2.2.5 Continuous activation c) in a SINGLE FAULT CONDITION of The mechanical system should be NE
c) the continuous activation system an design taking these requirements into
unacceptable RISK could arise, one or account. The information required here
more emergency stopping device(s) should be included in the DHF.
to quality service
are provided in the ME EQUIPMENT

(see 9.2.4). The risks caused by mechanical
hazards associated with accessibility to
Compliance is checked by inspection a trapping zone and reduced by use of
of the ME EQUIPMENT and the RISK the continuous activation of the
MANAGEMENT FILE. movement control are addressed?
RMF (page, section)

9.2.2.6 Speed of movement(s) The speed of movement(s) that The mechanical system should be NE
position parts of the ME EQUIPMENT design taking these requirements into
or PATIENT, where contact with the account. The information required here
ME EQUIPMENT could result in a should be included in the DHF.
HAZARDOUS SITUATION, shall be
limited so that the OPERATOR will The risks caused by mechanical
have adequate control of positioning hazards associated with the speed of
without resulting in an unacceptable movement are addressed?
RISK.
The overtravel (stopping distance) of
such movement, occurring after
operation of a control to stop the
movement, shall not result in an
unacceptable RISK.

MANAGEMENT FILE.
RMF (page, section)
to quality service


9.2.3.1 Unintended movement Controls shall be so positioned, This requirement does not make NE
(Other HAZARDS associated with recessed, or protected by other means reference to the RMF, the information
moving parts) so that they cannot be accidentally required for compliance should be
actuated, resulting in unacceptable covered in the DHF or Usability
RISK, unless ergonomic Engineering File and through
considerations for the intended application of the Usability Engineering
PATIENT dictate otherwise (e.g., Process.
PATIENT with special needs).

RMF (page, section)

9.2.3.2 Overtravel The RISK due to overtravel (past The mechanical system should be NE
range limits) of ME EQUIPMENT parts design taking these requirements into
shall be reduced to an acceptable account. The information required here
level. End stops or other stopping should be included in the DHF.
means shall be provided to act as the
ultimate travel limiting measure in both The risk caused by mechanical hazards
NORMAL CONDITION and SINGLE associated with the over travel are
FAULT CONDITION. addressed?
Such means shall have the
mechanical strength to withstand the
intended loading in NORMAL USE and
reasonably foreseeable misuse.
to quality service

of the ME EQUIPMENT, the RISK
MANAGEMENT FILE, specifications of
materials used, and the processing
specifications for these materials.
RMF (page, section)

9.2.4 Emergency stopping devices Where it is considered necessary to The mechanical system should be NE
have one or more emergency stopping design taking these requirements into
device(s), the emergency stopping account. The information required here
device shall comply with all the should be included in the DHF.
following requirements.
a) The emergency stopping device Does the equipment use emergency
shall reduce the RISK to an acceptable stopping devices?
level.
b) The proximity and response of the Are the risks caused by mechanical
OPERATOR to actuate the emergency hazards which are reduced by the use
stopping device can be relied on to of emergency stopping devices reduced
prevent HARM. to an acceptable level?
c) The emergency stopping device
actuator shall be readily accessible to
the OPERATOR.
d) Emergency stopping device(s) shall
not be part of the normal operation of
the ME EQUIPMENT.
e) Operation of an emergency
switching or stopping means shall
neither introduce a further HAZARD
nor interfere with the complete
to quality service
operation necessary to remove the

original HAZARD.
f) Emergency stopping device(s) shall
be able to break the full load of the
relevant circuit, taking into account
possible stalled motor currents and the
like.
g) Means for stopping of movements
shall operate as a result of one single
action.
h) The emergency stopping device
shall have an actuator colored red
designed to be distinctive and easily
identifiable from that of other controls.
i) An actuator that interrupts/opens
mechanical movements shall be
marked on, or immediately adjacent to,
the face of the actuator with symbol
IEC 60417-5638 (DB:2002-10) (see
Table D.1, symbol 18) or the word
“STOP”.
j) The emergency stopping device,
once actuated, shall maintain the ME
EQUIPMENT in the disabled condition
until a deliberate action, different from
that used to actuate it, is performed.
k) The emergency stopping device
shall be shown to be suitable for its
application.

MANAGEMENT FILE.
RMF (page, section)
to quality service

9.2.5 Release of PATIENT Means shall be provided to permit the The mechanical system should be NE
release of the PATIENT quickly and design taking these requirements into
safely in the event of breakdown of the account. The information required here
ME EQUIPMENT or failure of the should be included in the DHF.
power supply (see 11.8), activation of
a protective measure or emergency The risks caused by mechanical
stopping. Special attention shall be hazards associated with release of the
given to the following. patient addressed?
— Uncontrolled or unintended
movement of the ME EQUIPMENT
that could result in an unacceptable
RISK shall be prevented.
— Situations where the PATIENT is
subjected to unacceptable RISKS due
to the proximity of moving parts,
removal of normal exit routes, or other
HAZARDS, shall be prevented.
— When, after removal of
counterbalanced parts, other parts of
the ME EQUIPMENT can move in a
hazardous way, measures shall be
provided to reduce the RISK to an
acceptable level.

MANAGEMENT FILE.
RMF (page, section)
to quality service

9.3 HAZARD associated with Rough surfaces, sharp corners, and The mechanical system should be NE
surfaces, corners and edges edges of ME EQUIPMENT that could design taking these requirements into
result in an unacceptable RISK shall account. The information required here
be avoided or covered. should be included in the DHF.
In particular, attention shall be paid to
flange or frame edges and the removal The risks caused by mechanical
of burrs. hazards associated with surfaces,
corners and edges are addressed?
MANAGEMENT FILE.
RMF (page, section)

9.4.1 General (Instability HAZARDS) ME EQUIPMENT, other than FIXED The mechanical system should be NA
ME EQUIPMENT and HAND-HELD design taking these requirements into
ME EQUIPMENT, intended to be account. The information required here
placed on a surface such as a floor or should be included in the DHF.
a table shall not overbalance (tip over) This requirement does not make direct
or move unexpectedly, to the degree reference to the RMF
that it could present an unacceptable
RISK to the PATIENT, OPERATOR, or
other person.
Compliance is checked by the tests in

9.4.2 to 9.4.4 (inclusive). Each test is
to quality service
performed separately.
RMF (page, section)

9.4.2.2 Instability excluding transport
ME EQUIPMENT or its parts shall not This requirement only applies to NA
overbalance when placed in any equipment that must comply with the
position of NORMAL USE, excluding requirements for limited stability
any transport positions, on a plane equipment.
inclined at an angle of 5 from the The mechanical system should be
horizontal plane. design taking these requirements into
If the ME EQUIPMENT or its parts account. The information required here
overbalances when placed in any should be included in the DHF.
position of NORMAL USE, excluding This requirement does not make direct
any transport positions, on a plane reference to the RMF
inclined at an angle of 10 from the
horizontal plane, it shall carry a
warning notice stating that transport
should only be undertaken in a certain
condition that shall be clearly
described in the instructions for use or
marked on the ME EQUIPMENT with
an indication of the RESIDUAL RISK if
the ME EQUIPMENT or its parts
overbalances.
RMF (page, section)

9.4.2.3 Instability from horizontal and a) ME EQUIPMENT having a mass of The mechanical system should be NA
vertical forces 25 kg or more, other than FIXED ME design taking these requirements into
EQUIPMENT that is intended to be account. The information required here
used on the floor, shall not should be included in the DHF.
overbalance due to pushing, leaning, This requirement does not make direct
resting, etc. reference to the RMF
Surfaces of the ME EQUIPMENT
to quality service
where a RISK of overbalancing the ME

EQUIPMENT exists from pushing,
leaning, resting, etc., shall be
permanently marked with a CLEARLY
LEGIBLE warning of this RISK, e.g.,
by use of safety sign IEC 60878 Safety
34 (see Table D.2, safety sign 5).

and the following test:
b) ME EQUIPMENT, other than FIXED

ME EQUIPMENT, that is intended to
be used on the floor or on a table, shall
not overbalance due to sitting or
stepping unless a legible warning of
this RISK is provided on the ME
EQUIPMENT, e.g., by use of safety
signs IEC 60878 Safety 35 or IEC
60878 Safety 37 as appropriate (see
Table D.2, safety signs 6 and 7).

and by the following test:
RMF (page, section)

9.4.2.4.1 General (Castors and The means used for transportation of The mechanical system should be NA
wheels) MOBILE ME EQUIPMENT, e.g., design taking these requirements into
castors or wheels, shall not result in an account. The information required here
unacceptable RISK when the MOBILE should be included in the DHF.
ME EQUIPMENT is moved or parked This requirement does not make direct
in NORMAL USE. reference to the RMF
RMF (page, section)
to quality service

9.4.2.4.3 Movement over a MOBILE ME EQUIPMENT exceeding The mechanical system should be NE
threashold 45 kg shall be able to pass over a 20 design taking these requirements into
mm threshold. Passing over a 20 mm account. The information required here
threshold shall not result in an should be included in the DHF.
unacceptable RISK.
Are the risks caused by mechanical
Compliance is checked by the hazards associated with movement
following test: over a threshold addressed?
RMF (page, section)

9.4.3.1 c) Instability in transport c) MOBILE ME EQUIPMENT that is The mechanical system should be NA
(Instability from unwanted lateral intended to be used on the floor shall design taking these requirements into
movement including sliding) not result in an unacceptable RISK account. The information required here
due to unwanted lateral movement. should be included in the DHF.
This requirement does not make direct
Compliance is checked by the reference to the RMF
following test:
RMF (page, section)

9.4.3.2 Instability excluding transport a) MOBILE ME EQUIPMENT shall be The mechanical system should be NA
provided with wheel locks or with a design taking these requirements into
to quality service
braking system appropriate to the account. The information required here

intended modes of use and sufficient should be included in the DHF.
to ensure that unintended movement is This requirement does not make direct
prevented on an incline of 5 . reference to the RMF

following test:
b) TRANSPORTABLE or
STATIONARY ME EQUIPMENT that
is intended to be used on the floor
shall not result in an unacceptable
RISK due to unwanted lateral
movement.

following test:
RMF (page, section)

9.5.1 Protective means (Expelled Where expelled parts could result in an The mechanical system should be NE
parts HAZARD) unacceptable RISK, the ME design taking these requirements into
EQUIPMENT shall be provided with a account. The information required here
means for protecting against such should be included in the DHF.
RISK.
Have the risks caused by mechanical
Compliance is checked by assessment hazards associated with expelled parts
of the suitability of the protective been addressed?
means and by inspection of the RISK
MANAGEMENT FILE.
RMF (page, section)
to quality service


9.6.1 General (Acoustic energy, ME EQUIPMENT shall be designed so For devices with sources of acoustic NE
including infra- and ultrasound, and that human exposure to acoustic energy and vibration, there should be
vibration) energy and vibration shall not result in corresponding information in the RMF.
an unacceptable RISK. Additionally the design should take
these requirements into account. The
Compliance is checked by inspection information required here should be
of the RISK MANAGEMENT FILE included in the DHF and/or RMF.
(taking into account the audibility of
auditory alarm signals and PATIENT Have the risks caused by mechanical
sensitivity) and the tests indicated in hazards associated with acoustic
9.6.2 and 9.6.3. energy and vibration been addressed?
RMF (page, section)

9.6.2.2 Infrasound and ultrasound When applicable, the For devices with sources of infrasound NA
energy MANUFACTURER shall address the or ultrasound, there should be
RISKS associated with infrasound or corresponding information in the RMF.
ultrasound in the RISK Additionally the design should take
MANAGEMENT PROCESS. these requirements into account. The
information required here should be
Compliance is checked by inspection included in the DHF and/or RMF.
of the RISK MANAGEMENT FILE. NOTE: there are particular (-2-x)
standards for different types of
to quality service
Ultrasound which should be considered

as needed.
Have the risks caused by mechanical

hazards associated with infrasound and
ultrasound been addressed?
RMF (page, section)

9.7.1 General (Pressure vessels and The requirements of this subclause For devices with pressure vessels, NA
parts subject to pneumatic and apply to vessels and parts of ME there should be corresponding
hydraulic pressure) EQUIPMENT subject to pressure, the information in the RMF. Additionally the
rupture of which could result in an design should take these requirements
unacceptable RISK. into account. The information required
The parts of a pneumatic or hydraulic here should be included in the DHF
system that are used as a support and/or RMF.
system shall additionally comply with
the requirements in 9.8.
RMF (page, section)

9.7.2 Pneumatic and hydraulic parts Pneumatic and hydraulic parts of ME The mechanical system should be NE
EQUIPMENT or ACCESSORIES shall design taking these requirements into
be so designed that: account. The information required here
— no unacceptable RISK results from should be included in the DHF.
to quality service
loss of pressure or loss of vacuum;

— no unacceptable RISK results from Have risks caused by mechanical
a fluid jet caused by leakage or a hazards associated with pneumatic and
component failure; hydraulic parts been addressed?
— elements of the ME EQUIPMENT or
an ACCESSORY, and especially pipes
and hoses, that can lead to an
unacceptable RISK shall be protected
against harmful external effects;
— reservoirs and similar vessels (e.g.,
hydro-pneumatic accumulators) that
can lead to an unacceptable RISK are
automatically depressurized when the
ME EQUIPMENT is isolated from its
power supply (e.g., pulling out the
pneumatic plug at the connector
mounted on the facility wall). If this is
not possible, means shall be provided
for the isolation (e.g., cutting off from
the peripheral circuit), or local
depressurizing of reservoirs and
similar vessels, and pressure
indication;
— all elements that can remain under
pressure after isolation of the ME
EQUIPMENT or an ACCESSORY
from its power supply and that could
result in an unacceptable RISK shall
be provided with clearly identified
exhaust devices, and a warning label
drawing attention to the necessity of
depressurizing these elements before
any setting or maintenance activity on
the ME EQUIPMENT or
ACCESSORIES.

and examination of the RISK
MANAGEMENT FILE.
RMF (page, section)
to quality service


9.7.4 Pressure rating of ME The maximum pressure to which a part The mechanical system should be NE
EQUIPMENT parts of ME EQUIPMENT can be subjected design taking these requirements into
in NORMAL CONDITION and SINGLE account. The information required here
FAULT CONDITION shall not exceed should be included in the DHF.
the MAXIMUM PERMISSIBLE
WORKING PRESSURE for the part, Have the risks caused by mechanical
except as allowed for pressure relief hazards associated with pressure rating
devices in 9.7.7. of equipment parts been addressed?

of the MANUFACTURER’s data for the
component, inspection of the ME
EQUIPMENT, inspection of the RISK
MANAGEMENT FILE, and, where
RMF (page, section)

9.7.5 Pressure vessels A pressure vessel shall withstand a The mechanical system should be NA
HYDRAULIC TEST PRESSURE if design taking these requirements into
to quality service
both the following conditions are met: account. The information required here
— the pressure is greater than 50 kPa; should be included in the DHF.
and This requirement does not make direct
— the product of pressure and volume reference to the RMF
is greater than 200 kPa • l.
following tests:
RMF (page, section)

9.7.6 Pressure control device In ME EQUIPMENT for which 9.7.7 The mechanical system should be NA
requires a pressure-relief device, any design taking these requirements into
pressure-control device responsible for account. The information required here
regulating the pressure shall be should be included in the DHF.
capable of performing under RATED
load for 100,000 cycles of operation Have the risks caused by mechanical
and shall prevent the pressure from hazards associated with pressure
exceeding 90 % of the setting of the control devices been addressed?
pressure-relief device under any
condition of NORMAL USE.

RMF (page, section)
to quality service

9.7.7 Pressure relief device ME EQUIPMENT shall incorporate The mechanical system should be NA
pressure-relief device(s) where the design taking these requirements into
MAXIMUM PERMISSIBLE WORKING account. The information required here
PRESSURE could otherwise be should be included in the DHF.
exceeded.
A pressure-relief device shall comply Have the risks caused by mechanical
with all of the following requirements: hazards associated with a pressure-
a) it shall be connected as close as relief device been addressed?
reasonably practical to the pressure
vessel or parts of the system that it is
intended to protect;
b) it shall be so installed that it is
readily accessible for inspection,
maintenance, and repair;
c) it shall not be capable of being
adjusted or rendered inoperative
without the use of a TOOL;
d) it shall have its discharge opening
so located and directed that the
released material is not directed
towards any person;
e) it shall have its discharge opening
so located and directed that operation
of the device will not deposit material
on parts that could result in an
unacceptable RISK;
f) it shall be of adequate discharge
capacity to ensure that the pressure
will not exceed the MAXIMUM
PERMISSIBLE WORKING
PRESSURE of the system to which it
is connected by more than 10 % in the
event of a failure in the control of the
supply pressure;
g) there shall be no shut-off valve
between a pressure-relief device and
the parts that it is intended to protect;
h) the minimum number of cycles of
operation shall be 100,000, except for
one-time use devices such as bursting
disks.
to quality service

RMF (page, section)

9.8.1 General (HAZARDS Where ME EQUIPMENT parts are The mechanical system should be NE
associated with support systems) designed to support loads or to provide design taking these requirements into
actuating forces, the following account. The information required here
requirements shall be applied if a should be included in the DHF.
mechanical fault could constitute an This requirement does not make direct
unacceptable RISK. reference to the RMF.
— The construction of the support,
suspension, or actuation system shall Have the risks caused by hazards
be designed based upon Table 21 and arising from static, dynamic, vibration,
the TOTAL LOAD. impact and pressure loading, foundation
— Means of attachment of and other movements, temperature,
ACCESSORIES shall be designed environmental, manufacture and service
such that any possibility of incorrect conditions been addressed?
attachment that could result in an
unacceptable RISK is avoided. Where all the following failures
— The RISK ANALYSIS of support considered: excessive deflection, plastic
systems shall consider HAZARDS deformation, ductile or brittle fracture,
arising from static, dynamic, vibration, fatigue fracture, instability (buckling),
impact, and pressure loading, stress-assisted corrosion cracking,
foundation, and other movements, wear, material creep, and material
temperature, environmental, deterioration?
to quality service
manufacture, and service conditions.

— All likely failure effects shall be Were the following residual stresses
considered in the RISK ANALYSIS. resulting from the manufacturing
These include excessive deflection, process, e.g. machining, assembling,
plastic deformation, ductile or brittle welding, heat treatment or surface
fracture, fatigue fracture, instability coating considered?
(buckling), stress-assisted corrosion
cracking, wear, material creep,
material deterioration, and residual
stresses resulting from the
manufacturing PROCESSES, e.g.,
machining, assembling, welding, heat
treatment, or surface coating.
— The ACCOMPANYING
DOCUMENTS shall contain
instructions on attachment of
structures to a floor, wall, ceiling, etc.
making adequate allowances for
quality of the materials used to make
the connection and shall list the
required materials. Additionally there
shall be advice on checking the
adequacy of the surface of the
structure to which the parts will be
attached.
RMF (page, section)

9.8.2 TENSILE SAFETY FACTOR Support systems shall maintain The mechanical system should be NE
structural integrity during the design taking these requirements into
to quality service
EXPECTED SERVICE LIFE of the ME account. The information required here

EQUIPMENT. TENSILE SAFETY should be included in the DHF.
FACTORS shall not be less than those
shown in Table 21 unless an When not according to table 21, what
alternative method demonstrates alternative method was used to
structural integrity throughout the determine the tensile safety factor?
EXPECTED SERVICE LIFE of the ME
EQUIPMENT, or the support is a foot Have the risks related to the value of
rest. The requirements for foot rests the tensile factor been addressed?
are in 9.8.3.2 (a).
See Table 21
Compliance with 9.8.1 and 9.8.2 is

checked by inspection of the ME
EQUIPMENT, the RISK
MANAGEMENT FILE, the
specifications of materials used and
the processing specifications for these
materials.
When test results are part of relevant
information, testing consists of
gradually applying a test load to the
support assembly under test equal to
the TOTAL LOAD times the required
TENSILE SAFETY FACTOR. The
support assembly under test is to be in
equilibrium after 1 min, or otherwise
not result in an unacceptable RISK.
RMF (page, section)

to quality service
9.8.3.1 General (Strength of ME EQUIPMENT parts serving for The mechanical system should be NA
PATIENT or OPERATOR support or support or immobilization of design taking these requirements into
suspension systems) PATIENTS shall be designed and account. The information required here
manufactured so as to minimize the should be included in the DHF.
RISK of physical injuries and of
accidental loosening of fixings. Have the risks caused by mechanical
The SAFE WORKING LOAD of ME hazards associated with the support or
EQUIPMENT or its parts serving for suspension of the patient (including
support or suspension of PATIENTS or particular applications) been
OPERATORS shall be the sum of the addressed?
mass of the PATIENTS or the mass of
the OPERATORS plus the mass of
ACCESSORIES intended by
MANUFACTURERS to be supported
or suspended by the ME EQUIPMENT
or ME EQUIPMENT parts.
Unless otherwise stated by the
MANUFACTURER, supporting and
suspending parts for adult human
PATIENTS or OPERATORS shall be
designed for a PATIENT or
OPERATOR having a minimum mass
of 135 kg and ACCESSORIES having
a minimum mass of 15 kg.
Where a MANUFACTURER specifies
particular applications (e.g., pediatric
use), the maximum mass of the
PATIENT included in the SAFE
WORKING LOAD of the ME
EQUIPMENT or its parts serving for
support or suspension of PATIENTS
may be adapted. When the maximum
allowable value of the mass of the
PATIENT is less than 135 kg, that
value shall be marked on the ME
EQUIPMENT and described in
When the maximum allowable value of
the mass of the PATIENT is more than
135 kg, that value shall be described in
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of markings, ACCOMPANYING
DOCUMENTS, and the RISK
MANAGEMENT FILE.
RMF (page, section)

9.8.3.2 Static forces due to loading In analyzing loading forces and The mechanical system should be NA
from persons torques on support assemblies, the design taking these requirements into
part of the SAFE WORKING LOAD account. The information required here
representing the mass of the should be included in the DHF.
PATIENTS or OPERATORS is This requirement does not make direct
distributed on the support/suspension reference to the RMF.
surface in a manner representing the
human body (see the example in Have the risks caused by mechanical
Figure A.19). hazards associated with static forces
due to loading from persons been
In analyzing loading forces and addressed?
torques on support assemblies, the
part of the SAFE WORKING LOAD
representing the mass of
ACCESSORIES shall be deployed as
in NORMAL USE or, if not defined, at
the worst case position permitted by
the configuration or ACCESSORIES
attachment on the support/suspension
parts.
a) For a foot rest that is intended to
temporarily support a standing
PATIENT or OPERATOR, the whole
mass of the PATIENT or OPERATOR
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is distributed over an area of 0.1 m2.

specifications of materials used, and
materials, and the following test:
After the test, a foot rest and its fixings

that shows any damage or deflection
that could result in an unacceptable
RISK constitutes a failure.
b) For an area of support/suspension
where a PATIENT or OPERATOR can
sit, deflection of a support surface from
PATIENT or OPERATOR loading shall
not result in an unacceptable RISK.

materials, and the following test:
Any deflection of the

support/suspension system that could
result in an unacceptable RISK
RMF (page, section)
to quality service

9.8.3.3 Dynamic forces due to Where dynamic forces (due to sitting The mechanical system should be NA
loading from persons down, standing up, PATIENT handling design taking these requirements into
PROCESS, or the like) can be exerted account. The information required here
on equipment parts intended to should be included in the DHF.
support or suspend a PATIENT or This requirement does not make direct
OPERATOR in NORMAL USE, they reference to the RMF
shall not result in an unacceptable
RISK.
following test:
There shall be no loss of function or

structural damage that could result in
an unacceptable RISK.
RMF (page, section)

9.8.4.1 General (systems with a) A MECHANICAL PROTECTIVE The mechanical system should be NA
MECHANICAL PROTECTIVE DEVICE shall be provided when a design taking these requirements into
DEVICES) support system or any of its parts account. The information required here
impaired by wear have a TENSILE should be included in the DHF.
SAFETY FACTOR greater than or
equal to the values specified in rows 5 Does the equipment use mechanical
and 6 but less than those in rows 3 protective devices?
and 4 of Table 21.
b) The MECHANICAL PROTECTIVE Does the mechanical protective device
DEVICE shall: activate before travel (movement)
— be designed on the basis of TOTAL produces an unacceptable risk?
LOAD, which shall include the effects
of the SAFE WORKING LOAD when
applicable;
— have TENSILE SAFETY FACTORS
for all parts not less than those in row
7 of Table 21;
— activate before travel (movement)
produces an unacceptable RISK;
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— take into account 9.2.5 and 9.8.4.3.

materials.
RMF (page, section)

9.8.4.3 Mechanical PROTECTIVE If a MECHANICAL PROTECTIVE The mechanical system should be NA
DEVICE intended for single DEVICE is intended to function only design taking these requirements into
activation once, the following requirements shall account. The information required here
be fulfilled: should be included in the DHF.
— Further use of the ME EQUIPMENT
shall be impossible until the Does the equipment use mechanical
MECHANICAL PROTECTIVE DEVICE protective devices intended for single
has been replaced. activation?
— The ACCOMPANYING
DOCUMENTS shall instruct that once Where risks caused by mechanical
the MECHANICAL PROTECTIVE hazards which have been reduced by
DEVICE has been activated, the use of mechanical protective
SERVICE PERSONNEL are to be devices intended for single activation:
called, and the MECHANICAL
PROTECTIVE DEVICE must be
replaced before the ME EQUIPMENT
can be used again.
— The ME EQUIPMENT shall be
permanently marked with safety sign
7010-W001 (see Table D.2, safety
to quality service
sign 2).
— The marking shall be adjacent to
the MECHANICAL PROTECTIVE
DEVICE or so located that its relation
to the MECHANICAL PROTECTIVE
DEVICE is obvious to the person
performing service or repair.
Compliance is checked as follows:

— by inspection of the ME
EQUIPMENT, the ACCOMPANYING
DOCUMENTS, the RISK
MANAGEMENT FILE, specifications of
materials used, and the processing
specifications for these materials;
— a chain, cable (wire rope), band,
spring, belt, jack screw nut, pneumatic
or hydraulic hose, structural part, or
the like, employed to support a load, is
defeated (to test the MECHANICAL
PROTECTIVE DEVICE) by any
convenient means, thereby causing
the maximum normal load to fall from
the most adverse position permitted by
the construction of the ME
EQUIPMENT. If the system supports a
PATIENT or OPERATOR, the load is
to include the SAFE WORKING LOAD
defined in 9.8.3.1.
Any evidence of damage to a
MECHANICAL PROTECTIVE DEVICE
that would affect its ability to perform
its intended function constitutes a
failure.
RMF (page, section)
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9.8.5 Systems without A MECHANICAL PROTECTIVE The mechanical system should be NE
MECHANICAL PROTECTIVE DEVICE is not required if: design taking these requirements into
DEVICES — the support system parts are not account. The information required here
impaired by wear and have TENSILE should be included in the DHF.
SAFETY FACTORS greater than or
equal to the values specified in rows 1 Has the manufacturer determined that
and 2 of Table 21; or the use of mechanical protective
— the support system parts are devices in the equipment is not
impaired by wear but have TENSILE required?
SAFETY FACTORS greater than or
equal to the values specified in rows 3 Has the manufacturer justified the
and 4 of Table 21. reasons not to use mechanical
protective devices?
MANAGEMENT FILE.
RMF (page, section)

10.1.2 ME EQUIPMENT intended to The MANUFACTURER shall address For devices with sources of radiation, NA
produce diagnostic or therapeutic X- in the RISK MANAGEMENT there should be corresponding
radiation PROCESS the RISK from unintended information in the RMF. Additionally the
X-radiation from ME EQUIPMENT design should take these requirements
designed to produce X-radiation for into account. The information required
diagnostic and therapeutic purposes. here should be included in the DHF
See IEC 60601-1-3 and also see 1.3. and/or RMF.
to quality service
Additionally, there are particular (-2-x)

Compliance is checked by inspection standards for radiation emitting
of the RISK MANAGEMENT FILE. equipment that should be considered as
needed.
When applicable, has the manufacturer

identified hazards and hazardous
situations associated with production of
x-radiation in the risk management file?
RMF (page, section)

10.2 Alpha, beta, gamma, neutron When applicable, the For devices with sources of radiation, NA
and other particle radiation MANUFACTURER shall address in the there should be corresponding
RISK MANAGEMENT PROCESS the information in the RMF. Additionally the
RISKS associated with alpha, beta, design should take these requirements
gamma, neutron, and other particle into account. The information required
radiation. here should be included in the DHF
and/or RMF.
Compliance is checked by inspection Additionally, there are particular (-2-x)
of the RISK MANAGEMENT FILE. standards for radiation emitting
equipment that should be considered as
needed.

alpha, beta, gamma, neutron or other
particle radiation in the risk
management file?
to quality service

RMF (page, section)

10.3 Microwave radiation When applicable, the For devices with sources of radiation, NA
MANUFACTURER shall address in the there should be corresponding
RISKS associated with microwave design should take these requirements
radiation. into account. The information required
here should be included in the DHF
Compliance is checked by inspection and/or RMF.
of the RISK MANAGEMENT FILE. Additionally, there are particular (-2-x)
standards for radiation emitting
equipment that should be considered as
needed.

microwave radiation in the risk
management file?
RMF (page, section)
to quality service

10.5 Other visible electromagnetic When applicable, the For devices with sources of radiation, NA
radiation MANUFACTURER shall address in the there should be corresponding
RISKS associated with visible design should take these requirements
electromagnetic radiation, other than into account. The information required
that produced by lasers and light here should be included in the DHF
emitting diodes (see 10.4). and/or RMF.
Additionally, there are standards for
Compliance is checked by inspection visible (IEC 60825-x) radiation emitting
of the RISK MANAGEMENT FILE. equipment that should be considered as
needed.

visible electromagnetic radiation in the
risk management file?
RMF (page, section)

10.6 Infrared Radiation When applicable, the For devices with sources of radiation, NA
RISKS associated with infrared design should take these requirements
to quality service
radiation, other than that produced by into account. The information required
lasers and light emitting diodes (see here should be included in the DHF
10.4). and/or RMF.
Compliance is checked by inspection When applicable, has the manufacturer

of the RISK MANAGEMENT FILE. identified hazards and hazardous
infrared radiation in the risk
management file?
RMF (page, section)

10.7 Ultraviolet Radiation When applicable, the For devices with sources of radiation, NA
RISKS associated with ultraviolet design should take these requirements
radiation, other than that produced by into account. The information required
lasers and light emitting diodes (see here should be included in the DHF
10.4). and/or RMF.
Compliance is checked by inspection When applicable, has the manufacturer

of the RISK MANAGEMENT FILE. identified hazards associated with
production of ultraviolet radiation in the
risk management file?
RMF (page, section)
to quality service


Table 23 Allowable maximum These temperature limit values are For devices which fall under this clause NE
temperatures for ME Equipment applicable for touching the healthy skin (contact with 10% of the head of body),
parts that are likely to be touched of adults. They are not applicable the temperature limits should be
(11.1.1) when large areas of the skin (10 % of assessed with clinical input and the final
total body surface or more) can be in limits (if different from those listed here)
contact with a hot surface. This also shall be documented in the DHF.
applies in the case of skin contact with
over 10 % of the head surface. Where Has the manufacturer identified parts of
this is the case, appropriate limits shall the equipment that are likely to be
be determined and documented in the touched in normal condition or
RISK MANAGEMENT FILE. foreseeable misuse that can contact
more than 10% of the surface area
operator or patient's body or 10% of the
surface area of the patient's or
operator's head?
Has the manufacturer identified the

duration of continuous or aggregate
contact?
Has the manufacturer identified and

addressed such risks?
Has the risk management process

determined suitable limits for
temperature based on the risk
acceptability criteria and risk benefit
analysis in association with patient state
of health and whether adult, pediatric or
neonate?
to quality service
RMF (page, section)


Table 24 Allowable maximum a These temperature limit values are For devices which fall under this clause NE
temperatures for skin contact with applicable for the healthy skin of (contact with 10% of the head of body),
ME EQUIPMENT APPLIED PARTS adults. They are not applicable when the temperature limits should be
(11.1.1) large areas of the skin (10 % of total assessed with clinical input and the final
body surface or more) can be in limits (if different from those listed here)
contact with a hot surface. They are shall be documented in the DHF.
not applicable in the case of skin
contact with over 10 % of the head Has the manufacturer identified applied
surface. Where this is the case, parts of the equipment that can contact
appropriate limits shall be determined more than 10% of the surface area
and documented in the RISK operator or patient's body or 10% of the
MANAGEMENT FILE. surface area of the patient's or
operator's head during normal use or
b Where it is necessary for APPLIED foreseeable misuse?
PARTS to exceed the temperature
limits of Table 24 in order to provide Has the manufacturer identified and
clinical benefit, the RISK addressed such risks?
MANAGEMENT FILE shall contain
documentation showing that the Has the risk management process
resulting benefit exceeds any determined suitable limits for
associated increase in RISK. temperature based on the risk
acceptability criteria?
If the temperature limits exceed the

values in table 24, has a favorable risk
benefit analysis in association with the
patient state of health and whether
adult, pediatric or neonate been
documented?
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RMF (page, section)

11.1.2.1 APPLIED PARTS intended The temperature (hot or cold surfaces) The clinical effects should be reviewed NA
to supply heat to a PATIENT or (where appropriate) the clinical and documented in the DHF.
effects shall be determined and
documented in the RISK Is any part of the equipment intended to
MANAGEMENT FILE. The supply heat or otherwise intended to
temperatures and clinical effects shall cool the patient?
be disclosed in the instructions for use.
addressed the clinical risks associated
with hazards?
Has the manufacturer disclosed such

risks?
RMF (page, section)
to quality service

11.1.2.2 APPLIED PARTS not The limits of Table 24 shall apply. If The clinical effects should be reviewed NE
intended to supply heat to a the surface temperature of an and documented in the DHF.
PATIENT APPLIED PART exceeds 41 C, the
maximum temperature shall be Does the equipment have any applied
disclosed in the instructions for use parts that are not intended to supply
and the clinical effects with respect to heat or cool the patient that could in
characteristics such as body surface, normal use or foreseeable misuse
maturity of PATIENTS, medications exceed 41 C or cool below ambient
being taken, or surface pressure shall temperature?
be determined and documented in the
RISK MANAGEMENT FILE. Where 41
C is not exceeded, no justification is
required.
Surfaces of APPLIED PARTS that are
cooled below ambient temperatures
can also result in HAZARD and shall
be evaluated as part of the RISK
MANAGEMENT PROCESS.
RMF (page, section)

11.1.3 Measurments (temperature) Where engineering judgement by the The data required here should be NE
MANUFACTURER indicates that developed based on scientific review of
temperature limits cannot be the design. This review and its
exceeded, no measurement is conclusion should be documented in
required. Where such judgements the DHF.
indicate that the test corner will not
impact the measurements, it may be
to quality service
omitted. However, the rationale for

such judgement shall be documented
in the RISK MANAGEMENT FILE. If
the test corner is used, its surfaces
shall not exceed 90 C.
For ME EQUIPMENT parts that are
likely to be touched and for APPLIED
PARTS, the probability of occurrence
of contact and of the duration of
contact is determined and documented
in the RISK MANAGEMENT FILE.
Compliance with the requirements of
11.1.1 and 11.1.2 is checked by
inspection of the RISK
MANAGEMENT FILE and the
instructions for use, operation of ME
EQUIPMENT, and temperature
measurements as follows:
RMF (page, section)

11.1.3.e Test criteria (temperature) e) Test criteria Alternate methods should be developed NE
During the test, THERMAL CUT-OUTS based on a scientific review of the
are not deactivated. design. This review and its conclusion
The maximum temperature of a part is should be documented in the DHF.
determined by measuring the
temperature rise of the part under test Has the manufacturer identified
and adding it to the maximum allowed hazardous situations that relate to
ambient temperature specified in the maximum heating effect of nearby
technical description (see 7.9.3.1). surfaces.
to quality service
Where thermal regulatory devices

make this method inappropriate, If no hazardous situations are apparent
alternative methods for measurement has the manufacturer made appropriate
are justified in the RISK declarations in the RMF?
MANAGEMENT FILE.
Has the manufacturer identified all
conditions of intended use and
foreseeable misuse to determine
occurrence and duration of contact with
parts and applied parts that could be
touched.
RMF (page, section)

11.2.2.1 RISK of fire in an Oxygen In ME EQUIPMENT and ME This requirement only applies to NA
Rich Environment SYSTEMS, the RISK of fire in an devices intended for use in OXYGEN
OXYGEN RICH ENVIRONMENT shall RICH ENVIRONMENTS. These
be reduced as far as possible under devices should be designed with these
NORMAL CONDITION or SINGLE requirements taken into account.
FAULT CONDITIONS (as identified in This requirement does not make
11.2.3). An unacceptable RISK of fire specific reference to the RMF.
is considered to exist in an OXYGEN
RICH ENVIRONMENT when a source Has the manufacturer identified that
of ignition is in contact with ignitable there is a risk from fire from an oxygen
material and there is no means that rich environment?
would limit the spread of a fire.
Where scenario #3 is applicable, has
the manufacturer conducted a risk
assessment to determine hazards
associated with leaks or component
to quality service
failures causing a source of ignition

been conducted?
RMF (page, section)

11.2.2.1.a RISK of fire in an Oxygen a) * A source of ignition is considered For devices under the scope of this NA
Rich Environment to exist in an OXYGEN RICH requirement, any justifications for
ENVIRONMENT when any of the revised test procedures should be
following conditions exist in NORMAL documented in the DHF.
CONDITION and SINGLE FAULT
CONDITIONS (including voltage and
current):
1) the temperature of the material is
raised to its ignition temperature;
2) temperatures could affect solder or
solder joints causing loosening, short
circuiting or other failures that could
result in sparking or raising the
temperature of the material to its
ignition temperature;
3) parts affecting safety crack or
change their outer shape exposing
temperatures exceeding 300 C or
sparks (see (4) and (5) below) due to
overheating;
4) temperatures of parts or
components could exceed 300 C;
5) sparks provide adequate energy for
ignition by exceeding the limits of
Figure 35 to Figure 37 (inclusive).
to quality service
Items (4) and (5) address the worst

case where the atmosphere is 100 %
oxygen, the contact material (for item
(5) is solder and the fuel is cotton.
Available fuels and oxygen
concentrations should be taken into
consideration when applying these
specific requirements. Where
deviations from these worst case limits
are made (based on lower oxygen
concentrations or less flammable
fuels) they shall be justified and
documented in the RISK
MANAGEMENT FILE.
RMF (page, section)

11.2.2.1.b RISK of fire in an Oxygen b) The following configurations, alone For devices under the scope of this NA
Rich Environment or in combination as appropriate (as requirement, the information required
determined by the application of the here should be documented in the DHF.
RISK MANAGEMENT PROCESS), are
considered to provide an acceptable
RESIDUAL RISK of fire in an
OXYGEN RICH ENVIRONMENT.
1) Electrical components in a
compartment with an OXYGEN RICH
ENVIRONMENT shall have power
supplies with limited energy levels.
Those energy levels shall be less than
those which are considered to be
sufficient for ignition (see 11.2.2.1 (a)).
of the design and measurement or
calculation of power, energy, and
temperature values in NORMAL
CONDITION and SINGLE FAULT
CONDITION (as identified in 11.2.3).
or
2) * Compartments that contain parts
to quality service
or components that can be a source of

ignition (as defined in 11.2.2.1 (a)) only
under SINGLE FAULT CONDITION
(as identified in 11.2.3) and that can be
penetrated by oxygen (e.g., because
of an undetected leak) shall be
ventilated such that the oxygen
concentration will not exceed 25 %.
following test:
or
3) * A compartment that contains parts
or components that can be a source of
ignition (as defined in 11.2.2.1 (a)) only
under SINGLE FAULT CONDITION
(as identified in 11.2.3) is separated
from another compartment that
contains an OXYGEN RICH
ENVIRONMENT by sealing all joints
and any holes for cables, shafts, or for
other purpose. The effect of possible
leaks and failures under SINGLE
FAULT CONDITION (as identified in
11.2.3) that could cause ignition shall
be evaluated using a RISK
ASSESSMENT to determine the
appropriate maintenance intervals.
Compliance is checked by visual

inspection of the documentation
provided by the MANUFACTURER
including the RISK MANAGEMENT
FILE.
RMF (page, section)

11.2.2.2 External exhause outlets for External exhaust outlets of an For devices under the scope of this NA
OXYGEN RICH ENVIRONNMENT OXYGEN RICH ENVIRONMENT shall requirement, the information required
not be located so that RISK of ignition here should be documented in the DHF.
to quality service
occurs because of any electrical This requirement does not make

component (which could cause a spark specific reference to the RMF.
in NORMAL USE or SINGLE FAULT
CONDITION as identified in 11.2.3)
mounted on the outside of the ME
EQUIPMENT or an ME SYSTEM.
RISK of ignition is considered to be
sufficiently low if oxygen concentration
in the immediate surroundings of the
electrical component does not exceed
25 % under the least favorable
conditions of operation.

RMF (page, section)

11.3 Construction requirements for This subclause provides an alternative For devices that will follow this NE
fire ENCOLSURE of ME means of compliance with selected exception to compliance with Clause
EQUIPMENT HAZARDOUS SITUATIONS and fault 13.1.2, all parts of this clause shall be
conditions as identified in 13.1.2. In reviewed and the appropriate design
doing so, the following constructional input requirements should be developed
requirements shall be met or related to the design of the enclosure.
specifically analyzed in the RISK Other then the standard flammability
MANAGEMENT FILE, and if not met, items on the RMF, there should not
specific justification shall also be given need to be any additional items
specified. The RMF should reference
the testing required by this clause as
evidence the risk of fire from the device
have been mitigated to an acceptable
level. The evidence should be located
in the DHF.
Have the specific requirements of this

clause been employed to comply with
clause 13.1.2?
Has the manufacturer analyzed and

addressed risks of not complying with
to quality service
the constructional requirements and

showed that an equivalent level of risk /
benefit has been provided?
RMF (page, section)

11.5 ME EQUIPMENT and ME The MANUFACTURER’s RISK Possibility of fire and any associated NA
SYSTEMS intended for use in MANAGEMENT PROCESS shall mitigations must be covered in the Risk
conjuction with flammable agents address the possibility of fire and Management Process.
associated mitigations.
Is the equipment intended to (or can it
Compliance is determined by be foreseeable misuse) come into
inspection of the RISK contact with flammable agents?
MANAGEMENT FILE.
RMF (page, section)

to quality service
11.6.2 Overflow in ME EQUIPMENT If ME EQUIPMENT incorporates a This requirement applies only to NA

reservoir or liquid storage chamber equipment with a liquid reservoir.
that is liable to be overfilled or to There is no specific reference to the
overflow in NORMAL USE, liquid RMF, this requirement states that any
overflowing from the reservoir or MOP’s that become wet during the test
chamber shall not wet any MEANS OF should not create an unacceptable
PROTECTION that is liable to be RISK. Prior to the test the pass/fail
adversely affected by such a liquid, nor criteria should be set listing any parts
shall an unacceptable RISK be which cannot become wet during the
created. Unless restricted by a test. Additionally, the results should be
marking or by the instructions for use, reviewed to verify no parts which
no HAZARDOUS SITUATION (as became wet would create an
specified herein) or unacceptable unacceptable RISK.
RISK due to overflow shall develop if The evidence should be contained
TRANSPORTABLE ME EQUIPMENT within the DHF.
is tilted through an angle of 15 .
Compliance is checked by filling the Does a hazardous situation or
liquid reservoir completely and unacceptable risk due to overflow
subsequently adding a further quantity develop if transportable equipment is
equal to 15 % of the capacity of the tilted through an angle of 15 degrees?
reservoir, which is poured in steadily
over a period of 1 min. Review the manufacturers risk
TRANSPORTABLE ME EQUIPMENT management file for risk analysis and
is subsequently tilted through an angle risk evaluation.
of 15 in the least favorable direction(s)
(if necessary with refilling) starting Does wetting of uninsulated electrical
from the position of NORMAL USE. parts or electrical insulation of parts that
After these PROCEDURES, the ME could result in a hazardous situation
EQUIPMENT is to pass the occur?
appropriate dielectric strength and
LEAKAGE CURRENT tests and is to Review the manufacturers risk
show no signs of wetting of management file for risk analysis and
uninsulated electrical parts or electrical risk evaluation.
insulation of parts that could result in a
HAZARDOUS SITUATION.
RMF (page, section)
to quality service

11.6.3 Spillage on ME EQUIPMENT ME EQUIPMENT and ME SYSTEMS This requirement applies to equipment NE
and ME SYSTEM requiring the handling of liquids in which require liquids based on their
NORMAL USE shall be so constructed intended use/intended use environment.
that spillage does not wet parts that This should be identified during the
could result in a HAZARDOUS design input phase.
SITUATION. For equipment falling under this
requirement, the intended use/intended
Compliance is checked by the use environment should be reviewed to
following test. determine the following items needed to
The ME EQUIPMENT is positioned perform this test:
according to 5.4 (a). A quantity of 1. Liquid to be used
liquid is poured steadily on a point on 2. Quantity to be used
the top of the ME EQUIPMENT. The 3. Location of the spill
type of liquid, volume, duration of the 4. Duration of the spill
spill, and location (point) are 5. Pass/fail criteria
determined through application of the
RISK MANAGEMENT PROCESS. All This should be listed as a design input
test conditions are identified through requirement, with the verification test
inspection of the RISK specified as stated in the standard
MANAGEMENT FILE. using items 1-6 to write the test
After these PROCEDURES, the ME requirements.
EQUIPMENT is to pass the The evidence should be located in the
appropriate dielectric strength and DHF.
LEAKAGE CURRENT tests and is to
show no signs of wetting of Does the equipment require the
uninsulated electrical parts or electrical handling of liquids in normal use or
insulation of parts that could result in a foreseeable misuse?
HAZARDOUS SITUATION.
Could wetting of the equipment result in
a hazardous situation?
Has the manufacturer identified

hazardous situations relating to the
worst case volume and type of liquid?
Has the manufacturer identified

hazardous situations relating to the
worst location for the equipment to
spill? (should be - for the equipment to
be spilled on)
to quality service

RMF (page, section)

11.6.5 * Ingress of water or ENCLOSURES of ME EQUIPMENT If an IP rating is claimed, it must be NE
particulate matter into ME and ME SYSTEMS designed to give a tested. Following the test there can be
EQUIPMENT and ME SYSTEMS specified degree of protection against no hazardous situation resulting from
harmful ingress of water or particulate any ingress.
matter shall provide this protection in Additionally, dielectric strength and
accordance with the classification of leakage current tests shall be repeated.
IEC 60529. See also 7.2.9.
Compliance is checked by the tests of Does the equipment show no signs of
IEC 60529 with the ME EQUIPMENT bridging of insulation (or electrical
placed in the least favorable position of components) that could result in a
NORMAL USE and by inspection. hazardous situation in normal condition
After these PROCEDURES, the ME or in combination with a single fault
EQUIPMENT is to show no signs of condition?
bridging of insulation (or electrical
components) that could result in a Review the manufacturers risk
HAZARDOUS SITUATION in management file for risk analysis and
NORMAL CONDITION, or in risk evaluation.
combination with a SINGLE FAULT
CONDITION (based on a visual
inspection), followed by the
appropriate dielectric strength and
LEAKAGE CURRENT tests.
RMF (page, section)
to quality service

11.6.6 Cleaning and disinfection of ME EQUIPMENT, ME SYSTEMS, and The effects of cleaning/disinfection over NE
ME EQUIPMENT and ME their parts, including APPLIED PARTS the EXPECTED SERVICE LIFE of the
SYSTEMS and ACCESSORIES, shall be capable equipment should be considered during
of withstanding, without damage or the design.
deterioration of safety provisions, the Acceptance of the cleaning/disinfection
cleaning or disinfection PROCESSES should be a result of the verification
specified in the instructions for use. activities.
See also 7.9.2.12. Documentation should be located in the
The MANUFACTURER shall evaluate DHF.
the effects of multiple
cleanings/disinfections during the Has the manufacturer identified parts of
EXPECTED SERVICE LIFE of the ME the equipment which may be subject to
EQUIPMENT, ME SYSTEM, and their cleaning or disinfection in normal use or
parts and ACCESSORIES, and assure foreseeable misuse and the type of
that no unacceptable RISK will occur. cleaning or disinfection?
The results of the evaluation shall be
documented in the RISK Based on the ESL of the equipment ahs
MANAGEMENT FILE. the manufacturer extrapolated the
Where compliance with this standard number of cleaning processes to which
could be affected by cleaning or the equipment will be subjected?
disinfecting the ME EQUIPMENT, ME
SYSTEM, and their parts and Has the manufacturer identified all
ACCESSORIES, they are cleaned or related hazards and addressed such
disinfected once in accordance with risks in the RMF?
the methods specified including any
cooling or drying period. After these
PROCEDURES, the ME EQUIPMENT,
ME EQUIPMENT parts or
ACCESSORIES are to show no signs
of deterioration that could result in an
unacceptable RISK (visual inspection),
followed by the appropriate dielectric
strength and LEAKAGE CURRENT
tests. The RISK MANAGEMENT FILE
is inspected to verify that the
MANUFACTURER has evaluated the
affects of multiple cleanings.
to quality service

RMF (page, section)

11.6.7 Sterilization of ME ME EQUIPMENT, ME SYSTEMS, and This requirement applies only to NA
EQUIPMENT and ME SYSTEMS their parts or ACCESSORIES intended devices/components which are intended
to be sterilized shall be assessed and to be sterilized.
documented according to ISO 11134, These devices should be designed to
ISO 11135, or ISO 11137 as withstand the sterilization procedures
appropriate. See also 7.9.2.12. based on the EXPECTED SERVICE
After these PROCEDURES, the ME LIFE, verification tests should be
EQUIPMENT, ME SYSTEM, and their performed as stated here.
parts or ACCESSORIES are to show The evidence should be located in the
no signs of deterioration that could DHF.
result in an unacceptable RISK (visual
inspection) followed by the appropriate Has the manufacturer identified the
dielectric strength and LEAKAGE parts of the equipment which may be
CURRENT tests and by inspection of subject to sterilization in normal use or
the RISK MANAGEMENT FILE. foreseeable misuse and the type of
sterilization?
RMF (page, section)
to quality service

11.6.8 Compatability with When applicable, the Devices should be designed so that NA
substances used with the ME MANUFACTURER shall address in the substances intended to be used with
EQUIPMENT RISK MANAGEMENT PROCESS the the devices do not have a detrimental
RISKS associated with compatibility impact on the safety and/or function of
with substances used with the ME the device.
EQUIPMENT. Evidence should be located in the DHF.
NOTE: any additional hazards related to
Compliance is checked by inspection substances should be also captured in
of the RISK MANAGEMENT FILE. the RMF.

substances to which the equipment may
come into contact with in normal use or
foreseeable misuse?
RMF (page, section)

12.1 Accuracy of controls and When applicable, the See also particular standards (IEC NE
instruments MANUFACTURER shall address in the 60601-2-xx) for additional
RISK MANAGEMENT PROCESS the guidance/requirements.
RISKS associated with accuracy of Accuracy that is important to clinical
controls and instruments. function or safety should be identified
as a design input requirement. The
Compliance is checked by inspection evidence should be located in the DHF.
of the RISK MANAGEMENT FILE. NOTE: any additional hazards related to
accuracy should be also captured in the
to quality service
RMF.

controls and instruments contained on
the equipment?
Has the manufacturer conducted a

hazard analysis to identify the risks
associated with the accuracy of the
above identified controls and
instruments?
RMF (page, section)

12.2 USABILITY The MANUFACTURER shall address Compliance with this requirement is NE
in a USABILITY ENGINEERING achieved through application of the
PROCESS the RISK of poor Usability Engineering Process
USABILITY, including those Evidence should be located in the
associated with identification, marking, Usability Engineering File.
and documents (see 7.1.1 and 16.2).
See IEC 60601-1-6 and also see 1.3.

of the results of the USABILITY
ENGINEERING PROCESS.
RMF (page, section)
to quality service

12.3 Alarm systems When applicable, the During the design input phase, any NE
MANUFACTURER shall address in the alarms that are required for clinical
RISK MANAGEMENT PROCESS the functionality, safety or as a risk
need for alarm systems as means of mitigation shall be identified. IEC
RISK CONTROL and any RISKS 60601-1-8 shall be used for the
associated with their operation or design/verification of the alarm system.
failure to operate. See IEC 60601-1-8
and also see 1.3. Alarms which are a risk mitigation
should be listed in the RMF. Other
Compliance is checked by inspection evidence should be included in the
of the RISK MANAGEMENT FILE. DHF.
Has the manufacturer considered in

their option analysis the inclusion of
alarms as a means to mitigate the risk
of accuracy of controls and instruments
for controlling hazards against
hazardous outputs?
Has the use of alarms been

implemented as a means of mitigating
the risk of accuracy of controls and
instruments for controlling hazards
against hazardous outputs?
Has the manufacturer in their risk

analysis explored and addressed the
hazards of operation or failure of the
alarm systems?
Does the residual risk of such hazards

meet IEC 60601-1-8?
RMF (page, section)
to quality service


12.4.1 Intentional exceeding of When applicable, the This requirement applies where the NA
safety limits (Protection against MANUFACTURER shall address in the device allows the identified safe limits to
hazardous output) RISK MANAGEMENT PROCESS the be exceeded intentionally by the
RISKS associated with hazardous OPERATOR or by the EQUIPMENT
output arising from the intentional (e.g.; entering a mode on an imaging
exceeding of safety limits. device where the radiation exposure
can exceed the generally recognized
Compliance is checked by inspection safe limits for a specific
of the RISK MANAGEMENT FILE. treatment/patient).
Where applicable these items shall be
identified and the risks associated with
exceeding the limits should be included
on the RMF.
Has the manufacturer identified risks

associated with the intentional
exceeding of safety limits?
Has the manufacturer addressed such

risks to comply with the manufacturer's
risk acceptability criteria?
RMF (page, section)
to quality service

12.4.2 Indication of parameters When applicable, the During the deign input phase, all NA
relevant to safety (Protection against MANUFACTURER shall address in the parameters which will be indicated to
hazardous output) RISK MANAGEMENT PROCESS the the OPERATOR shall be identified
need for the indication of parameters (including those indicated as a risk
that are associated with hazardous mitigation).
output. Evidence should be included in the
DHF. Those items which are indicated
Compliance is checked by inspection specifically as a risk mitigation shall be
of the RISK MANAGEMENT FILE. included in the RMF.

functions related to the delivery of
energy or substances to the patient?
Has the manufacturer explored such

functions for hazardous situations in
which these functions can produce an
output to the patient?
RMF (page, section)

12.4.3 Accidental selection of Where ME EQUIPMENT is a multi- Where a device has both high & low NA
excessive output values (Protection purpose unit designed for providing intensity output the design shall include
against hazardous output) both low-intensity and high-intensity the requirements related to selection of
outputs for different treatments, the high/low intensity outputs.
MANUFACTURER shall address in the Any risks associated with incorrect
RISK MANAGEMENT PROCESS the selection should be evaluated as part of
RISKS associated with accidental the USABILITY ENGINEERING
selection of excessive output values. PROCESS where appropriate the
to quality service
evidence should be included in the RMF

Compliance is checked by inspection or the Usability Engineering File.
features of the equipment that provide
an output to the patient for therapeutic
purposes?
Has the manufacturer identified which

of these features have multiple
purposes that require different
intensities for different treatments?
Has the manufacturer identified hazards

associated with the accidental selection
of excessive output values?
RMF (page, section)

12.4.4 Incorrect output (Protection When applicable, the During the deign input phase, all NE
against hazardous output) MANUFACTURER shall address in the parameters which will be indicated to
RISK MANAGEMENT PROCESS the the OPERATOR shall be identified
RISKS associated with incorrect (including those indicated as a risk
output. mitigation).
Evidence should be included in the
Compliance is checked by inspection Usability Engineering File. Those items
of the RISK MANAGEMENT FILE. which are indicated specifically as a risk
mitigation shall be included in the RMF.
to quality service
features of the equipment that provide

an output?
Has the manufacturer identified hazards

associated with incorrect output?
RMF (page, section)

12.4.5.2 Diagnostic X-ray equipment When applicable, the Compliance with this requirements is NA
MANUFACTURER shall address in the through application of IEC 60601-1-3,
RISK MANAGEMENT PROCESS the and IEC 60601-2-54.
RISKS associated with diagnostic X- Additionally, for devices which utilize
rays. See IEC 60601-1-3 and also see diagnostic X-Rays, there should be
1.3. specific risks associated with x-rays
covered by the product RMF.
of the RISK MANAGEMENT FILE. Has the manufacturer identified if the
product emits intentional x-radiation for
diagnostic purposes?

explored risks associated with emission
of x-radiation for diagnostic purposes?
RMF (page, section)
to quality service


12.4.5.3 Radiotherapy equipment When applicable, the Compliance with this requirements is NA
MANUFACTURER shall address in the through application of the appropriate
RISK MANAGEMENT PROCESS the radiotherapy standards (e.g., IEC
RISKS associated with radiotherapy. 61217, IEC 61852, IEC 62274).
Additionally, for radiotherapy devices,
Compliance is checked by inspection specific risks should be covered by the
of the RISK MANAGEMENT FILE. product RMF.
Has the manufacturer identified if the

product is intended for radiotherapy
purposes?

radiation for therapeutic purposes?
RMF (page, section)

12.4.5.4 Other ME Equipment When applicable, the Compliance with this requirements is NA
producing diagnostic or therapeutic MANUFACTURER shall address in the through application the relevant IEC
radiation RISK MANAGEMENT PROCESS the standards based on the device type –
to quality service
RISKS associated with ME where no standards exist, IEC 60601-1-

EQUIPMENT producing diagnostic or 3 and/or IEC 60601-2-54 can be utilized
therapeutic radiation other than for as guidance.
diagnostic X-rays and radiotherapy Additionally, for devices which utilize
(see 12.4.5.2 and 12.4.5.3). diagnostic X-Rays, there should be
specific risks associated with x-rays
Compliance is checked by inspection covered by the product RMF.
product is intended for radiotherapy
purposes?

radiation for therapeutic purposes?
RMF (page, section)

12.4.6 Diagnostic or therapeutic When applicable, the Compliance with this requirement is NE
acoustic pressure MANUFACTURER shall address in the through application of the relevant IEC
RISK MANAGEMENT PROCESS the standards for the device type (e.g., IEC
RISKS associated with diagnostic or 60601-2-37).
therapeutic acoustic pressure. Additionally, any risks specific to
acoustic pressure should be listed in the
Compliance is checked by inspection RMF.
equipment emits an acoustic pressure
output?
to quality service

of such acoustic pressure?
RMF (page, section)

13.2.6 Leakage of liquid ME EQUIPMENT shall be so The design input and verification NA
constructed that liquid that might requirements should be developed
escape in a SINGLE FAULT taking this requirement into account.
CONDITION does not result in an The evidence required should be
unacceptable RISK. located in the DHF.
Since only small amounts of liquid will
escape when they leak, sealed Has the manufacturer determined the
rechargeable batteries are exempted appropriate test conditions for the
from this requirement. evaluation of liquid leakage?
A RISK MANAGEMENT PROCESS
shall be used to determine the
appropriate test conditions for the ME
EQUIPMENT.

RMF (page, section)
to quality service


14.1 General (PROGRAMMABLE The requirements of this clause shall Based on the assessment of NE
ELECTRICAL MEDICAL SYSTEMS) apply to PEMS unless: ESSENTIAL PERFORMANCE and a
— the PESS provides no BASIC review of the risks associated with
SAFETY or ESSENTIAL software failures if this exemption to all
PERFORMANCE; or the requirements in Clause 14 is taken,
— the application of ISO 14971 justification shall be included in the DHF
demonstrates that the failure of the and (where appropriate) the RMF.
PESS does not lead to an
unacceptable RISK. Does the application of ISO 14971
demonstrate that the failure of the
However, because a RISK PEMS does not lead to an
MANAGEMENT PROCESS is already unacceptable risk?
required by this standard, this clause
will define the minimum elements of
the PEMS DEVELOPMENT LIFE-
CYCLE and only the additional
elements for the PEMS that needs to
be considered as part of the RISK
MANAGEMENT PROCESS (see 4.2).
Compliance is determined by
application of the requirements in 14.2
to 14.13 (inclusive), by inspection of
the RISK MANAGEMENT FILE, and
assessment of PROCESSES cited in
this clause.
RMF (page, section)
to quality service

14.2 PEMS documentation In addition to the RECORDS and There are specific additions to the NE
documents required by ISO 14971, the requirements of ISO 14971 contained
documents produced from application within some of the sections of Clause
of clause 14 shall be maintained and 14. These additions shall be covered in
shall form part of the RISK the RISK MANAGEMENT PROCESS
MANAGEMENT FILE. for a device that falls under the scope of
Clause 14 of this standard.
The documents required by clause 14
shall be reviewed, approved, issued,
and changed in accordance with a
formal document control
PROCEDURE.
RMF (page, section)

14.3 Risk Management Plan The RISK MANAGEMENT plan Compliance with this requirement may NE
required by ISO 14971, 3.5 shall also be achieved through application of IEC
include a reference to the PEMS 62304 incorporated with the Risk
VALIDATION plan (see 14.11). Management Process.
Does the risk management plan include

a reference to the PEMS validation
plan?
RMF (page, section)

14.4 PEMS Development Life-Cycle A PEMS DEVELOPMENT LIFE- Compliance with this requirement may NE
CYCLE shall be documented. be achieved through application of IEC
62304.
The PEMS DEVELOPMENT LIFE-
CYCLE shall include a set of defined Does each milestone in the PEMS
milestones. development life cycle identify the risk
to quality service
At each milestone, the activities to be management activities that must be

completed and the VERIFICATION completed before that milestone?
methods to be applied to those
activities shall be defined.
Each activity shall be defined including
its inputs and outputs.
Each milestone shall identify the RISK
MANAGEMENT activities that must be
completed before that milestone.
CYCLE shall be tailored for a specific
development by making plans which
detail activities, milestones, and
schedules.
CYCLE shall include documentation
requirements.
RMF (page, section)

14.5 Problem Resolution (PEMS) Where appropriate, a documented Compliance with this requirement may NE
system for problem resolution within be achieved through application of IEC
and between all phases and activities 62304
of the PEMS DEVELOPMENT LIFE-
CYCLE shall be developed and
maintained.
Depending on the type of product, the
problem resolution system may:
— be documented as a part of the
PEMS DEVELOPMENT LIFE-CYCLE;
— allow the reporting of potential or
existing problems affecting BASIC
SAFETY or ESSENTIAL
PERFORMANCE;
— include an assessment of each
problem for associated RISKS;
— identify the criteria that must be met
for the issue to be closed;
— identify the action to be taken to
to quality service
resolve each problem.

RMF (page, section)

14.6.1 Identification of known and When compiling the list of known or Compliance with this requirements is NE
foresseable HAZARDS (PEMS) foreseeable HAZARDS, the though application of the Risk
MANUFACTURER shall consider Management Process.
those HAZARDS associated with
software and hardware aspects of the Has the manufacturer considered those
PEMS including those associated with hazards associated with the software
NETWORK/DATA COUPLING, and hardware aspects of the PEMS
components of third-party origin and including those associated with
legacy subsystems. Network/Data coupling and legacy
systems?
RMF (page, section)

14.6.2 Risk Control (PEMS) The following requirements for PEMS Compliance with this requirement is NE
supplement subclause 6.1 of ISO through application of IEC 62304
14971. incorporated with the Risk Management
Suitably validated TOOLS and Process.
PROCEDURES shall be selected and
identified to implement each RISK Has the manufacturer identified suitable
CONTROL measure. tools and procedures to implement risk
These TOOLS and PROCEDURES control measures?
shall be appropriate to assure that
each RISK CONTROL measure Are these tools and procedures
satisfactorily reduces the identified appropriate to ensure that each risk
RISK(s). control measure effectively reduces the
identified risks?
RMF (page, section)
to quality service

14.7 Requirements specification For the PEMS and each of its Compliance with this requirement may NE
(PEMS) subsystems (e.g., for a PESS) there be achieved through application of IEC
shall be a documented requirement 62304.
specification.
Does the requirement specification
The requirement specification for a include and distinguish any risk control
system or subsystem shall include and measures?
distinguish any ESSENTIAL
PERFORMANCE and any RISK
CONTROL measures implemented by
that system or subsystem.
RMF (page, section)

14.8 Architecture For the PEMS and each of its Compliance with this requirement may NE
subsystems, an architecture shall be be achieved through application of IEC
specified that shall satisfy the 62304 taking into account the specific
requirement specification. items listed here.
Where appropriate, to reduce the RISK
to an acceptable level, the architecture Does the architecture specification
specification shall make use of: reduce the risk to an acceptable level,
a) COMPONENTS WITH HIGH- where appropriate, using levels a) - f)?
INTEGRITY CHARACTERISTICS;
b) fail-safe functions; Does the architecture specification take
c) redundancy; into consideration allocation of risk
d) diversity; control measures?
e) * partitioning of functionality;
f) defensive design, e.g., limits on
potentially hazardous effects by
restricting the available output power
or by introducing means to limit the
travel of actuators.
to quality service
The architecture specification shall

take into consideration:
g) * allocation of RISK CONTROL
measures to subsystems and
components of the PEMS;
NOTE—Subsystems and components
include sensors, actuators, PESS, and
interfaces.
h) failure modes of components and
their effects;
i) common cause failures;
j) systematic failures;
k) test interval duration and diagnostic
coverage;
l) maintainability;
m) protection from reasonably
foreseeable misuse;
n) the NETWORK/DATA COUPLING
specification, if applicable.
RMF (page, section)

14.9 Design and implementation Where appropriate, the design shall be Information related to the design NE
(PEMS) decomposed into subsystems, each environment should be located in the
having both a design and test DHF.
specification.
Descriptive data regarding the design Is descriptive data regarding the design
environment shall be included in the environment included in the risk
RISK MANAGEMENT FILE. management file?
RMF (page, section)
to quality service

14.10 Verification (PEMS) VERIFICATION is required for all VERIFICATION information should be NE
functions that implement BASIC located in the DHF.
SAFETY, ESSENTIAL
PERFORMANCE, or RISK CONTROL Is the result of the verification activity
measures. documented?
A VERIFICATION plan shall be
produced to show how these functions Have all functions that implement risk
shall be verified. The plan shall control measures been verified?
include:
— at which milestone(s)
VERIFICATION is to be performed for
each function;
— the selection and documentation of
VERIFICATION strategies, activities,
techniques, and the appropriate level
of independence of the personnel
performing the VERIFICATION;
— the selection and utilization of
VERIFICATION TOOLS; and
— coverage criteria for
VERIFICATION.
The VERIFICATION shall be

performed according to the
VERIFICATION plan. The results of
the VERIFICATION activities shall be
documented.
RMF (page, section)

14.11 PEMS VALIDATION A PEMS VALIDATION plan shall Information regarding VALIDATION NE
include the validation of BASIC should be located in the DHF.
SAFETY and ESSENTIAL
PERFORMANCE, and shall require Has the manufacturer documented the
checks for unintended functioning of professional relationships of the
the PEMS. members of the PEMS validation team
to quality service
The PEMS VALIDATION shall be with members of the design team?

performed according to the PEMS
VALIDATION plan. The results of Is a reference to the methods and
PEMS VALIDATION activities shall be results of the PEMS validation included
documented. in the risk management file?
The person having the overall
responsibility for the PEMS
VALIDATION shall be independent of
the design team. The
MANUFACTURER shall document the
rationale for the level of independence.
No member of a design team shall be
responsible for the PEMS
VALIDATION of their own design.
All professional relationships of the
members of the PEMS VALIDATION
team with members of the design team
shall be documented in the RISK
MANAGEMENT FILE.
A reference to the methods and results
of the PEMS VALIDATION shall be
included in the RISK MANAGEMENT
FILE.
RMF (page, section)

14.13 Connection of PEMS by If the PEMS is intended to be There is no direct reference to the RMF NE
NETWORK/DATA COUPLING to connected by NETWORK/DATA in this requirement.
other equipment COUPLING to other equipment that is Compliance with this clause may be
outside the control of the PEMS satisfied by application of IEC/ISO
MANUFACTURER, the technical 80001-1.
description shall:
a) specify the characteristics of the Is there a list of the hazardous
NETWORK/DATA COUPLING situations resulting from a failure of the
necessary for the PEMS to achieve its network/data coupling provided with the
INTENDED USE; specified characteristics?
b) list the HAZARDOUS SITUATIONS
to quality service
resulting from a failure of the Review the manufacturers risk

NETWORK/DATA COUPLING to management file for any risk analysis,
provide the specified characteristics; risk evaluation and any necessary risk
c) instruct the RESPONSIBLE control measures.
ORGANIZATION that:
— connection of the PEMS to a Does a connection of the PEMS to a
NETWORK/DATA COUPLING that network/data coupling that includes
includes other equipment could result other equipment result in previously
in previously unidentified RISKS to unidentified risks to patients, operators
PATIENTS, OPERATORS or third or third parties?
parties;
— the RESPONSIBLE Review the manufacturers risk
ORGANIZATION should identify, management file for any risk analysis,
analyze, evaluate, and control these risk evaluation and any necessary risk
RISKS; control measures.
— subsequent changes to the
NETWORK/DATA COUPLING could
introduce new RISKS and require
additional analysis; and
— changes to the NETWORK/DATA
COUPLING include:
— changes in NETWORK/DATA
COUPLING configuration;
— connection of additional items to the
NETWORK/DATA COUPLING;
— disconnecting items from the
NETWORK/DATA COUPLING;
— update of equipment connected to
the NETWORK/DATA COUPLING;
— upgrade of equipment connected to
the NETWORK/DATA COUPLING.
RMF (page, section)
to quality service

15.1 Arrangement of controls and When applicable, the Compliance with this requirement is NE
indicators of ME Equipment MANUFACTURER shall address in the through application of a Usability
RISK MANAGEMENT PROCESS the Engineering Process; the evidence
RISKS associated with the required should be listed in the Usability
arrangement of controls and indicators Engineering File.
of ME EQUIPMENT.
Compliance is checked by inspection risk management process the risks
of the RISK MANAGEMENT FILE. associated with the arrangement of
controls and indicators?
Inspect for the arrangement of controls

and indicators.
RMF (page, section)

15.2 Serviceability Parts of ME EQUIPMENT subject to There is no specific reference to the NE
mechanical wear, electrical, and RMF in this clause.
environmental degradation or aging
that could result in an unacceptable Information on the design related to
RISK if allowed to continue unchecked service shall be included in the DHF.
for too long a period shall be
accessible for inspection, replacement,
and maintenance.
Parts of ME EQUIPMENT that are
likely to be replaced or adjusted shall
be so located and secured as to permit
inspection, servicing, replacement, and
to quality service
adjustment without damage to, or

interference with, adjacent parts or
wiring.

of the parts mentioned above in this
subclause and of their location.
RMF (page, section)

15.3.1 General (Mechanical ME EQUIPMENT or its parts shall There is no direct reference to the RMF NE
Strength) have adequate mechanical strength in this clause. Information on the
and shall not result in an unacceptable design the enclosure shall be located in
RISK due to molding stress or when the DHF.
subjected to mechanical stress caused The requirements of this clause should
by pushing, impact, dropping, and be identified as design input
rough handling. requirements with reference to Table 28
Compliance is checked by application to determine which sections of this
of the tests in Table 28. The tests are clause are applicable to specific
not applied to handles, levers, knobs, devices.
the face of cathode ray tubes (see
9.5.2), or to transparent or translucent
covers of indicating or measuring
devices unless with the handle, lever,
knob, or cover removed there is an
unacceptable RISK of electric shock.
NOTE—Examples of damage that can
result in unacceptable RISK include
the reduction of CREEPAGE
DISTANCES and AIR CLEARANCES
below those specified in 8.9, access to
parts which exceed limits in 8.4, or
access to moving parts which could
cause HARM.
Assessment criteria that can be useful
in determining if the tests in Table 28
have resulted in an unacceptable RISK
include:
— those in clause 8 and 11.6;
to quality service
— the dielectric strength test as

specified in 8.8.3 to evaluate the
integrity of solid SUPPLEMENTARY or
REINFORCED INSULATION; and
— measurement of CREEPAGE
DISTANCES or AIR CLEARANCES to
compare the values with the minimum
distances specified in 8.9.
Small chips that do not adversely
affect the protection against electric
shock or moisture can normally be
ignored.
RMF (page, section)

15.3.2 Push Test ENCLOSURES of ME EQUIPMENT The requirements of this clause should NE
shall have sufficient rigidity to protect be identified as design input
against unacceptable RISK. requirements with reference to Table 28
to determine which sections of this
Compliance is checked by the clause are applicable to specific
following test. devices.
(this requirement applies to all types of
After the test, any damage sustained equipment).
that results in an unacceptable RISK,
as determined by inspection of the After the push test, were damages
RISK MANAGEMENT FILE, sustained that result in an unacceptable
constitutes a failure. risk identified?
RMF (page, section)

to quality service
15.3.3 Impact Test ENCLOSURES of ME EQUIPMENT The requirements of this clause should NE
shall have sufficient resistance to be identified as design input
impact to protect against unacceptable requirements with reference to Table 28
RISK. to determine which sections of this
clause are applicable to specific
Compliance is checked by the devices.
following test. (this requirement does not apply to
HAND-HELD equipment).
After the test, any damage sustained
that results in an unacceptable RISK, After the impact test, were damages
as determined by inspection of the sustained that resulted in an
RISK MANAGEMENT FILE, unacceptable risk identified?
RMF (page, section)

15.3.4.1 HAND-HELD ME HAND-HELD ME EQUIPMENT and The requirements of this clause should NA
EQUIPMENT (Drop test) ME EQUIPMENT parts that are be identified as design input
HAND-HELD shall not result in an requirements with reference to Table 28
unacceptable RISK as a result of a to determine which sections of this
free fall. clause are applicable to specific
devices.
following test.
After the test, the HAND-HELD ME

EQUIPMENT and ME EQUIPMENT
parts that are HAND-HELD shall not
result in an unacceptable RISK.
RMF (page, section)
to quality service

15.3.4.2 Portable ME Equipment RPORTABLE ME EQUIPMENT and The requirements of this clause should NE
(Drop test) ME EQUIPMENT parts that are be identified as design input
PORTABLE shall withstand the stress requirements with reference to Table 28
caused by a free fall from the height to determine which sections of this
indicated in Table 29 onto a hard clause are applicable to specific
surface. devices.
Compliance is checked by the After the drop test, were damages

following test. sustained that resulted in an
unacceptable risk identified?
After the test, any damage sustained
that results in a unacceptable RISK, as
determined by inspection of the RISK
MANAGEMENT FILE and inspection
of the ME EQUIPMENT or the ME
EQUIPMENT parts that are
PORTABLE, constitutes a failure.
RMF (page, section)

15.3.5 Rough handling test MOBILE ME EQUIPMENT and ME The requirements of this clause should NE
EQUIPMENT parts that are MOBILE be identified as design input
shall withstand the stress caused by requirements with reference to Table 28
rough handling and movement and to determine which sections of this
shall not result in an unacceptable clause are applicable to specific
RISK. devices.
(This requirement does not apply to
Compliance is checked by the HAND-HELD or PORTABLE
following tests. Equipment).
a) Ascending step shock After the rough handling test, were

damages sustained that resulted in an
to quality service
b) Descending step shock unacceptable risk identified?
c) Door frame shock
After each test, any damage sustained

that results in an unacceptable RISK,
as determined by inspection of the
RISK MANAGEMENT FILE and
inspection of the ME EQUIPMENT or
the ME EQUIPMENT parts that are
MOBILE, constitutes a failure.
RMF (page, section)

15.3.6 Mold stress relief test ENCLOSURES of molded or formed The requirements of this clause should NE
thermoplastic materials shall be so be identified as design input
constructed that any shrinkage or requirements with reference to Table 28
distortion of the material due to release to determine which sections of this
of internal stresses caused by the clause are applicable to specific
molding or forming operation does not devices.
result in an unacceptable RISK. (This requirement applies only to
enclosures formed or molded from
Compliance is checked by inspection thermoplastic materials)
of the construction and available data
were appropriate or by the following
test.
There shall not be any damage

resulting in an unacceptable RISK.
RMF (page, section)
to quality service

15.3.7 Environmental influences The selection and treatment of There is no reference to the RMF in this NE
materials used in the construction of requirement.
ME EQUIPMENT shall take account of The evidence required should be
the INTENDED USE, the EXPECTED located in the DHF.
SERVICE LIFE, and the conditions for
transport and storage.
The ME EQUIPMENT shall be so
designed and constructed that during
its EXPECTED SERVICE LIFE any
corrosion, aging, mechanical wear, or
degradation of biological materials due
to the influence of bacteria, plants,
animals, and the like, shall not reduce
its mechanical properties in a way that
results in an unacceptable RISK. See
also 15.2.
Compliance is checked by inspection:

— of the ME EQUIPMENT, of the
ACCOMPANYING DOCUMENTS, and
of the MANUFACTURER’s
specifications of materials used, and of
materials;
— of the MANUFACTURER’s relevant
tests or calculations.
RMF (page, section)

15.4.1 Construction of connectors Design and construction of electrical, Compliance with this requirement NE
hydraulic, pneumatic, and gas should be accomplished through
connection terminals and connectors application of the relevant connector
of ME EQUIPMENT shall be such that standard(s) (e.g., ISO 8039-x).
incorrect connection of accessible Where no standard exists, the design
connectors, removable without the use should accomplish the requirements
of a TOOL, shall be prevented where listed here.
to quality service
an unacceptable RISK would Documentation regarding the design or

otherwise exist. In particular: selection of connectors to comply with
a) Plugs for connection of PATIENT this requirement should be located in
leads shall be so designed that they the DHF.
cannot be connected to other outlets
on the same ME EQUIPMENT Has the manufacturer identified
intended for other functions, unless it electrical, hydraulic and pneumatic or
can be proven that no unacceptable gas connection terminals and
RISK can result. connectors removable without the use
b) Medical gas connections on ME of a tool where incorrect connection to
EQUIPMENT for different gases to be other outlets intended for other
operated in NORMAL USE shall not be functions would not result in an
interchangeable. See also ISO 407 unacceptable risk?
[28].
Ensure that incorrect connection does
Compliance is checked by inspection not result in an unacceptable risk. (Gas
of the RISK MANAGEMENT FILE. connectors must comply with item b) of
this clause).
RMF (page, section)

15.4.2.1.a) Application a) THERMAL CUT-OUTS and OVER- During the design input phase, the NE
(Temperature and overload control CURRENT RELEASES with automatic requirements listed here should be
devices) resetting shall not be used in ME identified as design inputs. Where
EQUIPMENT if their use could result in appropriate, information regarding risks
a HAZARDOUS SITUATION by such associated with fire or burns can be
resetting. found in the RMF. Specific information
related to the design in accordance with
Compliance is checked by inspection this clause should be located in the
of the RISK MANAGEMENT FILE. DHF.
to quality service

risk management file, any automatic
resetting thermal cut-outs or over-
current releases where their use would
not result in an unacceptable risk?
Ensure that the resetting of these

devices does not result in unacceptable
risk.
RMF (page, section)

15.4.2.1.b) Application b) THERMAL CUT-OUTS with a safety During the design input phase, the NE
(Temperature and overload control function that have to be reset by a requirements listed here should be
devices) soldering operation that can affect the identified as design inputs. Where
operating value shall not be fitted in appropriate, information regarding risks
ME EQUIPMENT. associated with fire or burns can be
found in the RMF. Specific information
Compliance is checked by inspection related to the design in accordance with
of the design documentation and the this clause should be located in the
RISK MANAGEMENT FILE. DHF.

risk management file the use of thermal
cut-outs with a safety function?
Ensure that such components are not of

the types that have to be reset by a
soldering operation that can affect the
operating value.
RMF (page, section)
to quality service


15.4.2.1.c) Application c) In ME EQUIPMENT, where a failure During the design input phase, the NE
(Temperature and overload control of a THERMOSTAT could constitute a requirements listed here should be
devices) HAZARD an independent non- identified as design inputs. Where
SELFRESETTING THERMAL CUT- appropriate, information regarding risks
OUT shall additionally be provided. associated with fire or burns can be
The temperature of operation of the found in the RMF. Specific information
additional device shall be outside that related to the design in accordance with
attainable at the extreme setting of the this clause should be located in the
normal control device but shall be DHF.
within the safe temperature limit for its
intended function. Has the manufacturer identified the use
of a thermostat in the equipment in the
Compliance is checked by inspection risk management file?
of the design documentation and the
RISK MANAGEMENT FILE. Inspect for an independent non-self-
resetting thermal cut-out with a setting
outside the maximum range of the
thermostat but within the safe
temperature limit for its intended
function.
RMF (page, section)

15.4.2.1.d) Application d) Loss of function of the ME During the design input phase, the NE
(Temperature and overload control EQUIPMENT caused by operation of a requirements listed here should be
devices) THERMAL CUT-OUT or OVER- identified as design inputs. Where
CURRENT RELEASE shall not result appropriate, information regarding risks
in a HAZARDOUS SITUATION. associated with fire or burns can be
to quality service

Has the manufacturer identified that

loss of function of the equipment could
result in a hazardous situation?
Ensure that the operation of a thermal

cut-out or over-current release does not
result in an unacceptable risk.
RMF (page, section)

15.4.2.1.h) Application (Temperature h) ME EQUIPMENT that incorporates During the design input phase, the NE
and overload control devices) tubular heating elements shall have requirements listed here should be
protection against overheating in both identified as design inputs. Where
leads where a conductive connection appropriate, information regarding risks
to earth could result in overheating. associated with fire or burns can be
Has the manufacturer identified the

need for fusing each lead for the use of
tubular heating elements in the risk
management file?
Inspect for fuses in both leads and fault

either lead to ground to ensure over-
heating does not occur.
to quality service
RMF (page, section)


15.4.3.1 Housing (Batteries) In ME EQUIPMENT, housings Devices with batteries should be NE
containing batteries from which gases designed taking this requirement into
that are likely to result in a HAZARD account.
can escape during charging or General RISKS associated with the use
discharging shall be ventilated to of batteries should be included in the
minimize the RISK of accumulation RMF.
and ignition.
Battery compartments of ME Has the manufacturer identified the
EQUIPMENT shall be designed to need for ventilating battery housings
prevent accidental short circuiting of where gases could result in a hazard
the battery where such short circuits can escape during charging or
could result in a HAZARDOUS discharging?
SITUATION.
Inspect the battery housings for proper
Compliance is checked by inspection ventilation.
of the design documentation and the
RISK MANAGEMENT FILE. Has the manufacturer identified the
need for battery polarity connection
construction such that short-circuiting is
not possible?
Inspect the battery connection and

ensure that incorrect connection is not
possible.
RMF (page, section)

to quality service
15.4.3.2 Connection If a HAZARDOUS SITUATION might Battery connections shall not be NE

develop by the incorrect connection or reversible unless it can be shown that
replacement of a battery, ME no hazardous situation results from the
EQUIPMENT shall be incorrect connection.
fitted with a means of preventing
incorrect polarity of connection. See If a hazardous situation might develop
also 7.3.3 and 8.2.2. by the incorrect connection or
replacement of a battery, verify the
Compliance is checked by inspection. equipment is fitted with a means of
preventing incorrect polarity of
connection.

management file for any risk analysis.
RMF (page, section)

15.4.3.3 Protection against Where overcharging of any battery of Devices with batteries should be NE
overcharging ME EQUIPMENT could result in an designed taking this requirement into
unacceptable RISK, the design shall account.
prevent overcharging.
Does overcharging of any battery of
Compliance is checked by inspection equipment result in an unacceptable
of the design documentation. risk, the design shall prevent
overcharging?

RMF (page, section)
to quality service

15.4.3.4 Lithium batteries Lithium batteries used in ME Lithium batteries shall comply with IEC NE
EQUIPMENT that could become a 60086-4 unless it can be shown that
HAZARD shall comply with the there is no hazard associated with the
requirements of IEC 60086- use of the lithium battery.
4. See also 7.3.3.
Do lithium batteries used in equipment
Compliance is checked by inspection that could become a hazard comply
of the battery design documentation or with the requirements of IEC 60086-4?
by performance of the tests identified
in IEC 60086-4. Review the manufacturers risk
RMF (page, section)

15.4.3.5 Excessive current and An INTERNAL ELECTRICAL POWER Devices with batteries should be NE
voltage protection SOURCE in ME EQUIPMENT shall be designed taking this requirement into
provided with an appropriately RATED account.
device for protection against fire General RISKS associated with the use
caused by excessive currents if the of batteries should be included in the
cross-sectional area and layout of the RMF.
internal wiring or the rating of
connected components can give rise Has the manufacturer provided
to a fire in case of a short circuit. justification for the omission of fuses or
Protective devices shall have over-current releases in the risk
adequate breaking capacity to interrupt management file?
the maximum fault current (including
short-circuit current) which can flow. Protection against fire caused by
Justification for omission of fuses or excessive currents is by inspection of
OVER-CURRENT RELEASES shall the design and risk management file
be included in the RISK and no additional testing is required.
MANAGEMENT FILE.
to quality service
for the presence of protective means

and, if necessary, by inspection of the
design documentation and the RISK
MANAGEMENT FILE.
RMF (page, section)

15.4.4 * Indicators Unless it is otherwise apparent to the Indicator lights, indicating that non- NE
OPERATOR from the normal luminous heaters are operational shall
operating position, indicator lights shall be provided unless it is apparent to the
be provided to indicate that ME operator from the normal operating
EQUIPMENT is ready for NORMAL position or no hazardous situation exists
USE. The marking of 7.4.1 is not without the indication.
sufficient for this purpose. This does not apply to heated stylus-
If equipped with a stand-by state or a pens.
warm-up state whose duration Indicator lights indicating an equipment
exceeds 15 s, the ME EQUIPMENT output exists when accidental or
shall be provided with an additional prolonged use of the output could
indicator light unless it is otherwise constitute a hazardous situation.
apparent to the OPERATOR from the
normal operating position. Are indicator lights provided on
equipment incorporating non-luminous
Indicator lights shall be provided on heaters to indicate that the heaters are
ME EQUIPMENT incorporating non- operational, if a hazardous situation
luminous heaters to indicate that the could exist unless it is otherwise
heaters are operational, if a apparent to the operator from the
HAZARDOUS SITUATION could exist normal operating position?
unless it is otherwise apparent to the
OPERATOR from the normal Review the manufacturers risk
operating position. management file for any risk analysis.
to quality service
Indicator lights shall be provided on Are indicator lights provided on

ME EQUIPMENT to indicate that an equipment to indicate that an output
output exists where an accidental or exists where an accidental or prolonged
prolonged operation of the output operation of the output circuit could
circuit could constitute a HAZARDOUS constitute a hazardous situation?
SITUATION.
Colors of indicator lights are described management file for any risk analysis.
in 7.8.1.
In ME EQUIPMENT incorporating a
means for charging an INTERNAL
ELECTRICAL POWER SOURCE, the
charging mode shall be visibly
indicated to the OPERATOR.

of the presence and function of
indicating means visible from the
position of NORMAL USE.
RMF (page, section)

15.4.5 Pre-set controls When applicable, the If the device will have any pre-set NE
MANUFACTURER shall address in the controls they should be designed taking
RISK MANAGEMENT PROCESS the the risks into account. Any risks
RISKS associated with pre-set associated with preset controls (and
controls. their accidental resetting e.g., due to
power loss) should be captured in the
Compliance is checked by inspection RMF.
Where applicable, has the manufacturer
addressed the risk associated with pre-
set controls?
to quality service

RMF (page, section)

15.4.6.2 Limitation of movement Stops of adequate mechanical There is no reference to the RMF in this NE
(control knobs) strength shall be provided on rotating requirement.
or movable parts of controls of ME Equipment with rotating controls shall
EQUIPMENT, where necessary to be designed taking these requirements
prevent an unexpected change from into account.
maximum to minimum, or vice-versa,
of the controlled parameter where this
could produce a HAZARDOUS
SITUATION.

and manual tests. For rotating
controls, the torques as shown in
Table 30 are applied for not less than
2 s in each direction alternately. The
test is repeated 10 times.
If an axial pull is likely to be applied to
the rotating or movable parts of
controls of ME EQUIPMENT in
NORMAL USE, no unacceptable RISK
shall develop.
RMF (page, section)

to quality service

15.4.7.1 Mechanical strength (Cord- a) HAND-HELD control devices of ME There is no direct reference to the RMF NA
connected HAND-HELD and foot- EQUIPMENT shall comply with in this requirement.
operated control devices) 15.3.4.1. Devices with HAND-HELD control
b) Foot-operated control devices of ME devices and foot-operated controls shall
EQUIPMENT shall be able to support be designed taking these requirements
the weight of an adult human being. into account.
Compliance is checked by application
to the foot-operated control device, in
its position of NORMAL USE, of an
actuating force of 1,350 N for 1 min.
The force is applied over an area of 30
mm diameter. There shall be no
damage to the device resulting in an
unacceptable RISK.
RMF (page, section)

15.4.7.2 Accidental operation of ME HAND-HELD and foot-operated control There is no direct reference to the RMF NA
EQUIPMENT devices shall not result in an in this requirement.
unacceptable RISK by changing their Devices with HAND-HELD control
control setting when accidentally devices and foot-operated controls shall
placed in an abnormal position. be designed taking these requirements
Compliance is checked by turning the into account.
control device in all possible abnormal
positions and placing it on a flat
surface.
Any inadvertent change of control
setting resulting in an unacceptable
RISK constitutes a failure.
RMF (page, section)

15.4.7.3 b) Entry of liquids b) In ME EQUIPMENT, Compliance with a) is achieved through NA
to quality service
ENCLOSURES of foot operated application of the IPX1 (or greater)

control devices that contain electrical testing from IEC 60529.
circuits shall be classified at least IPX6 Compliance with b) is achieved through
according to IEC 60529 if they are application of the IPX6 (or greater)
intended for NORMAL USE in areas testing in accordance with IEC 60529.
where liquids are likely to be found The intended use should be reviewed to
(such as emergency rooms and determine if the intended use
operating theatres). The probability of environment stipulates that IPX6 or
occurrence shall be estimated as part greater rating should be applied. The
of the RISK MANAGEMENT rating shall be specified as a design
PROCESS. input requirement (or verification test).
Evidence should be located in the DHF.
Compliance is determined by
inspection of the ACCOMPANYING Has the manufacturer conducted risk
DOCUMENTS, the design analysis for foot operated control
documentation, the RISK devices during their risk management
MANAGEMENT FILE, and by process?
performing the appropriate tests of IEC
60529. Is the probability of occurrence of the
intended normal use in areas where
liquids are likely to be found low enough
such that foot-operated control devices
that contain electrical circuits do not
have to be classified as IPX6 according
to IEC 60529.
Than perform testing at the

manufacturer's lesser IPX_ rating.
NOTE IPX1 is the minimum rating.
If not, than verify compliance to IPX6

classification.

RMF (page, section)
to quality service

16.1 General requirements for ME After installation or subsequent There is no reference to the RMF in this NE
SYSTEMS modification, an ME SYSTEM shall not requirement.
result in an unacceptable RISK.
Only HAZARDS arising from For evaluation of ME SYSTEMS, the
combining various equipment to verification requirements should specify
constitute an ME SYSTEM shall be the “worst case” system configurations
considered. which need to be evaluated for
An ME SYSTEM shall provide: this standard.
— within the PATIENT
ENVIRONMENT, the level of safety After installation or subsequent
equivalent to ME EQUIPMENT modification, does the system result in
complying with this standard; and an unacceptable risk?
— outside the PATIENT
ENVIRONMENT, the level of safety Have hazards arising from combining
equivalent to equipment complying various equipment to constitute a
with their respective IEC or ISO safety system been considered?
standards.
Tests shall be performed: Is the level of safety equivalent to a
— in NORMAL CONDITION unless system complying with this standard
otherwise specified, and IEC 60601-1 within the patient
— under the operating conditions environment?
specified by the MANUFACTURER of
the ME SYSTEM. If the system is reconfigurable, have
Safety tests that have already been risk management methods been used
performed on individual equipment of to determine which configurations
the ME SYSTEM according to relevant constitute the highest risks and which
standards shall not be repeated. measures are needed to ensure that the
The MANUFACTURER of an ME reconfiguration does not constitute an
SYSTEM that is (re)configurable by unacceptable risk?
the RESPONSIBLE ORGANIZATION
or OPERATOR may use RISK
MANAGEMENT methods to determine
which configurations constitute the
highest RISKS and which measures
are needed to ensure that the ME
SYSTEM in any possible configuration
does not present an unacceptable
RISK.
Non-ME EQUIPMENT, when used in
an ME SYSTEM, shall comply with
to quality service
IEC or ISO safety standards that are

relevant to that equipment.
Equipment in which protection against
electric shock relies only on BASIC
INSULATION shall not be used in an
ME SYSTEM.
of appropriate documents or
certificates.
RMF (page, section)

16.2 ACCOMPANYING An ME SYSTEM, (including a modified There is no direct reference to the RMF NE
DOCUMENTS of an ME SYSTEM ME SYSTEM), shall be accompanied in this requirement.
by documents containing all the data ME SYSTEMS should be designed (or
necessary for the ME SYSTEM to be configured) taking the requirements of
used as intended by the this clause into account.
MANUFACTURER, and an address to
which the RESPONSIBLE
ORGANIZATION can refer. The
ACCOMPANYING DOCUMENTS shall
be regarded as a part of the ME
SYSTEM.
These documents shall include:

a) the ACCOMPANYING
DOCUMENTS for each item of ME
EQUIPMENT that is provided by the
MANUFACTURER (see 7.8.2);
b) the ACCOMPANYING
DOCUMENTS for each item of non-
ME EQUIPMENT that is provided by
the MANUFACTURER;
c) the following information:
to quality service
— the specification of the ME

SYSTEM, including the use as
intended by the MANUFACTURER
and a listing of all of the items forming
the ME SYSTEM;
— instructions for the installation,
assembly, and modification of the ME
SYSTEM to ensure continued
compliance with this standard;
— instructions for cleaning and, when
applicable, disinfecting and sterilizing
each item of equipment or equipment
part forming part of the ME SYSTEM
(see 11.6.6 and 11.6.7);
— additional safety measures that
should be applied, during installation of
the ME SYSTEM;
— which parts of the ME SYSTEM are
suitable for use within the PATIENT
ENVIRONMENT;
— additional measures that should be
applied during preventive
maintenance;
— if a MULTIPLE SOCKET-OUTLET
is present and it is a separate item, a
warning that it shall not be placed on
the floor;
— a warning that an additional
MULTIPLE SOCKET-OUTLET or
extension cord shall not be connected
to the ME SYSTEM;
— a warning to connect only items that
have been specified as part of the ME
SYSTEM or that have been specified
as being compatible with the ME
SYSTEM;
— the maximum permitted load for any
MULTIPLE SOCKET-OUTLET(s) used
with the ME SYSTEM;
— an instruction that MULTIPLE
SOCKET-OUTLETS provided with the
ME SYSTEM shall only be used for
supplying power to equipment that is
to quality service
intended to form part of the ME

SYSTEM;
— an explanation of the RISKS of
connecting non-ME EQUIPMENT that
has been supplied as a part of the ME
SYSTEM directly to the wall outlet
when the non-ME EQUIPMENT is
intended to be supplied via a
MULTIPLE SOCKET-OUTLET with a
separating transformer;
— an explanation of the RISKS of
connecting any equipment that has not
been supplied as a part of the ME
SYSTEM to the MULTIPLE SOCKET-
OUTLET;
— the permissible environmental
conditions of use of the ME SYSTEM
including conditions for transport and
storage; and
— instructions to the OPERATOR not
to touch parts referred to in 16.4 and
the PATIENT simultaneously;
d) advice to the RESPONSIBLE
ORGANIZATION:
— to carry out all adjustment cleaning,
sterilization, and disinfection
PROCEDURES specified therein; and
— that the assembly of ME SYSTEMS
and modifications during the actual
service life require evaluation to the
requirements of this standard.

RMF (page, section)

16.9.1 Connection terminals and Design and construction of electrical, Accessible connectors shall not be NE
connectors hydraulic, pneumatic, and gas removable without the use of a tool
connection terminals and connectors unless it can be shown that no
to quality service
shall be such that incorrect connection hazardous situation exists.

of accessible connectors, removable Connectors for patient leads shall be
without the use of a TOOL, shall be designed so that they cannot connect to
prevented where a HAZARDOUS other outlets on the ME or MES located
SITUATION could otherwise exist. in the patient environment unless it can
— Connectors shall comply with be shown that no hazardous situation
15.4.1. can result.
— Plugs for connection of PATIENT
leads shall be so designed that they Are the design and construction of
cannot be connected to other outlets of electrical, hydraulic, pneumatic and gas
the same ME SYSTEM that are likely connection terminals and connectors
to be located in the PATIENT such that incorrect connection of
ENVIRONMENT unless it can be accessible connectors, removable
proved that no HAZARDOUS without the use of a tool, can be
SITUATION can result. prevented where a hazardous situation
could otherwise exist?
and, if possible, by interchanging Review the manufacturers risk
connectors. management file for any risk analysis,
risk evaluation and risk control
measures.
Are plugs for patient leads designed to

prevent connection to other outlets of
the same system that are likely to be
located in the patient environment
unless no hazardous situation can
result?

management file for any risk analysis,
risk evaluation and risk control
measures.
RMF (page, section)
to quality service

17 Electromagnetic compatability of The MANUFACTURER shall address Compliance with this clause is through NE
ME Equipment and ME Systems In the RISK MANAGEMENT application of IEC 60601-1-2.
PROCESS the RISKS associated with: Prior to testing to this standard, the
— the electromagnetic phenomena pass/fail criteria should be determined.
existing at the locations where the ME Any results that arise that are not
EQUIPMENT or ME SYSTEM is expected should be reviewed to
intended to be used as indicated in the determine if they are acceptable.
ACCOMPANYING DOCUMENTS; and Evidence should be located in the DHF.
— the introduction by the ME
EQUIPMENT or ME SYSTEM of Does the risk management process
electromagnetic phenomena into the address the risks associated with the
environment that might degrade the electromagnetic phenomena existing at
performance of other devices, the locations where the equipment or
electrical equipment, and systems. system is intended to be used as
See IEC 60601-1-2 and also see 1.3. indicated in the accompanying
documents?
of the RISK MANAGEMENT FILE. Does the risk management process
address the risks associated with the
introductions by the equipment or
system of electromagnetic phenomena
into the environment that might degrade
the performance of other devices,
electrical equipment, and systems?
RMF (page, section)
to quality service
Risk Management Assessment Tracking:

Table 4 Documentation Review Tracking
Record documents reviewed during the assessment in the table below
Document Page/Section Revision/Date Notes

Table 5 Risk Management Non-Conformity Tracking

Record any identified questions or non-conformities in the table below along with the
response/resolution. All items must be identified as closed before a certification report can be
issued.
Clause/Document Question/Issue Response Date Closed

Software (PEMS) Assessment Tracking:

The following tabulation may assist manufacturers in preparing a submittal package for products
that require compliance with Clause 14. For more detail of the document content, please
consult the identified clauses from IEC 60601-1. This inventory represents a maximum amount
of documentation. We understand that the documents referenced in many of the identified
clauses may be combined into one document. The term Procedures can be a single or multiple
documents.
Table 6 Inventory of documents for PEMS - Clause 14

Document
IEC 60601-1 Page /
Documentation Requirement Document Name Date or
Clause Section
Version
Document Control Procedures 14.2
1. Name
2. Designation
3. Revision number
4. Revision history
5. Date
6. Authorizations
Configuration Management 14.2, 14.4

Procedures
1. Version number for each
PESS
2. Software to software
integration
3. Hardware to software
integration
4. Production
5. Modification/change control
(clause 52.211)
6. Authorizations
Risk Management Plan or 14.3

Procedures
1. Hazard identification
method(s) including reference
to standards
2. Hazard analysis method(s),
including reference to
standards, risk control
methods such as design
attributes defined risk-
addressed state for product
assignment of risk mitigation
to subsystem, etc.

Document
IEC 60601-1 Page /
Clause Section
Version
Risk Management Summary 14.3, 14.4,

14.6.1,
1. Traceability throughout 14.6.2,
development life-cycle for 14.10
verification of implemented
risk management
requirements
It shall contain:
a) identified HAZARDS and their

initiating causes;
b) estimation of RISK;
c) reference to the SAFETY

measures, used to eliminate or
control the RISK of the HAZARD;
d) evaluation of effectiveness of
RISK control;
e) reference to VERIFICATION.
Document Control Procedures 14.2
7. Name
8. Designation
9. Revision number
10. Revision history
11. Date
12. Authorizations
Configuration Management 14.2, 14.4
Procedures
7. Version number for each PESS

8. Software to software integration
9. Hardware to software integration
10. Production
11. Modification/change control (clause
14.12)
12. Authorizations
Risk Management Plan or

Document
IEC 60601-1 Page /
Clause Section
Version
Procedures 14.3
3. Hazard identification method(s)
including reference to standards
4. Hazard analysis method(s), including
reference to standards, risk control
methods such as design attributes
defined risk-addressed state for
product assignment of risk
mitigation to subsystem, etc.
Risk Management Summary 14.3, 14.4,

14.6.1, 14.6.2,
2. Traceability throughout
14.10
development life-cycle for
verification of implemented risk
management requirements
It shall contain:
a) identified HAZARDS and their initiating

causes;
b) estimation of RISK;
c) reference to the SAFETY measures, used

to eliminate or control the RISK of the
HAZARD;
d) evaluation of effectiveness of RISK

control;
e) reference to VERIFICATION.
Programmable System Development Life- 14.4

Cycle Plan or Procedures
Modification/Change Control Procedures 14.4, 14.12
1. Rationale for change

2. Effect of change on risk control
3. Authorizations
Personnel assigned to development of 14.4

PEMS and PESS recorded
1. The term “assigned task” includes

qualification and responsibility

Document
IEC 60601-1 Page /
Clause Section
Version
Hazard Analysis 14.6.1
1. System level
2. Software level
Results of Hazard Analysis 14.6.1
Hazard List and Initiating Causes 14.6.1
(Risk Management Summary)
14.6.1
Record of Estimated Risk for each

Identified Hazard
1. Before risk control is applied
Risk Control Requirements 14.6.2
Record of Estimation for the Effectiveness 14.6.1, 14.6.2

of Risk Controls
2. Estimated residual risk after risk

control requirements are
implemented
3. Record (verification and validation)
of risk reduction
PEMS Requirements Specification 14.7
PESS Requirements Specification
1. Traceable to the hazard analysis

Document
IEC 60601-1 Page /
Clause Section
Version
PEMS Architecture Specification 14.8
Subsystems Architecture Specification

2. Traceable to the requirements
specification
Design Specification for each PESS with 14.9

verification method

specification
3. Traceable to the architectural
specification
Verification Plan or Procedures 14.10
Verification Methods and Results 14.10

specification
3. Traceable to the architectural
specifications
4. Traceable to the design
specifications
Validation Plan or Procedures 14.11
Validation Methods and Results 14.11

2. Traceable to the risk control
requirements
3. Intended use and user needs

Document
IEC 60601-1 Page /
Clause Section
Version
Technical description that includes 14.13

information about network/data coupling
to other equipment.

Table 6 PEMS Non-Conformity Tracking

Record any identified questions or non-conformities in the table below along with the
response/resolution. All items must be identified as closed before a certification report can be
issued.
Clause/Document Question/Issue Response Date Closed

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Risk Management Guidance & Report:

© 2012 Medical Equipment Compliance Associates - All Rights Reserved

An editable version of this document is available to MECA customers - please contact us

© 2012 Medical Equipment Compliance Associates - All Rights Reserved

An editable version of this document is available to MECA customers - please contact us

Product/Product Family Version, Configuration etc.

© 2012 Medical Equipment Compliance Associates - All Rights Reserved

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Definitions and Acronyms

NOTE: All definitions of IEC 60601-1:2005, ISO 14971:2000 apply

© 2012 Medical Equipment Compliance Associates - All Rights Reserved

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IECEE Test Report Form No IEC60601_1G

IECEE Operational Document OD-2044-Ed.1.0

Report & Template Ownership and Revision History

Template Revision History

Report Revision History

© 2012 Medical Equipment Compliance Associates - All Rights Reserved

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Instructions for completing Table 3

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Figure 1: Example Risk Table

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Table 3 Risk Management Results Tables

Compliance is checked by inspection

— established acceptable levels of

IEC 60601-1:2005 Requirement

Have risk control measures or tests

Have these items been confirmed

IEC 60601-1:2005 Requirement

IEC 60601-1:2005 Requirement

requirements of this standard. RMF it is assumed that the documented

Are there particular risks for which

Were these risks deemed acceptable?

Is the resulting residual risk equal to or

IEC 60601-1:2005 Requirement

to the requirements for APPLIED acceptable method to minimize the

Have parts been identified during the

Are the relevant requirements and tests

Are there residual risks deemed not

Are there risk control meausres

IEC 60601-1:2005 Requirement

mentioned in 3.1, shall be simulated,

Compliance is determined by applying

IEC 60601-1:2005 Requirement

IEC 60601-1:2005 Requirement

6.3 - Implementation of Risk Control NE

IEC 60601-1:2005 Requirement

For the determination of which

IEC 60601-1:2005 Requirement

For the testing of the equipment, have

IEC 60601-1:2005 Requirement

20 C to + 32 C. Before being placed

IEC 60601-1:2005 Requirement

IEC 60601-1:2005 Requirement

Compliance is checked by inspection

IEC 60601-1:2005 Requirement

IEC 60601-1:2005 Requirement

RMF (page, section)

IEC 60601-1:2005 Requirement

IEC 60601-1:2005 Requirement