EMC

Correlation between Product Life Cycle of

Medical Devices and 3rd Edition of IEC60601-1 Radio

Telecom

Presented by Michael Brun Environmental

Product Safety Group Manager &
Customer Solutions Specialist
brun@hermonlabs.com
Product Safety

International Approvals
Agenda
10:15-11:15 - Correlation between Product Life Cycle of Medical Devices
and IEC60601-1 3rd Ed.

With Zoom-in on requirements “external” to IEC60601 standard

presented by invited speakers

• Risk Analysis
• Biocompatibility
• Sterilization

13:00-13:45 - Lunch

13:45-14:30 - Integration of “external” requirements into IEC60601 TRF

14:30-15:15 - Accreditation issues: GLP vs. ISO17025

15:30-16:15 - Clinical Trials – presented by invited speakers

16:15-17:00 - Questions and Answers.

Time Dimension: MD Life Cycle
Regulatory requirements should be considered from very beginning of
new MD concept development and testing, and through all its life.

To determine applicable standard may not be simple! To synchronize

with relevant standard version which will be mandatory at time of MD
placement on the market is even more difficult!

IEC and ISO standards development projects typically take 3–5 years.

When EN and UL/CSA adopt IEC harmonized standards, it takes another 1-2
years to issue them as a European and N. America national standards.

After that, normally 3-4 years transition period to allow industry to move to new
standard before withdrawal of superseded standard.
Transition to new standard in 1 year!
The latest version of IEC 60601-1, its 3rd Edition “Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance”, was published in 2005.

National standards for IEC 60601-1 3rd Edition were published in Europe, USA and Canada.
They can be used now as an option, and will become mandatory in 1 year from now.
How to comply?
1. To determine market
In today's regulatory environment, most of the technical EMC and safety requirements
are the same or very similar between various countries. For instance, almost all emission
requirements are based on the international CISPR standards, and almost all national
safety standards are based on same IEC standard.

However, the regulatory requirements are very different.

Different countries have differing accreditation requirements for test laboratories, and
different approach to component requirements, quality assurance, factory inspections
and certification maintenance.

2. To design equipment in compliance with regulatory requirements of

target market.

3. To test equipment for compliance with relevant standards in a test

lab that has suitable accreditations for the countries for which you
need approvals.
IEC 60601
60601--X-XX Standards structure
Collateral standards IEC 60601
60601--1-XX

General standard Systems EMC

IEC 60601-
60601-1 60601--1-1
60601 60601--1-2
60601

Particular standards
IEC 60601-
60601-2-XX
IEC 60601
60601--2-10
Amendments
IEC 60601
60601--2-XX
IEC 60601
60601--2-24
IEC 60601-
60601-2-XX
Integration Example: EMC vs. Safety
1. Electrical Interfaces and Insulation
Insulation properties, EMC filters, Surge protectors, Cabling, PCB layout

2. Enclosure construction.

Opening dimensions, materials, exact position of components.

3. Grounding.

Connection to main protective earth, protective boding, GND layers of PCB.

4. Labeling and Instructions.

May be critical issue for small or modular products.

Safety is more predictable, therefore normally EMC testing is made

first, providing there is high level of confidence about safety
compliance.
Why 90% of Medical Products Do Not Comply
Statistics Information below and some slides were copied from presentation by Michael
Brousseau, Engineering Team Leader of Medical Devices Group, Intertek

“Major IEC 60601-1 3rd Ed. Changes - Why 90% of Medical Products Do Not Comply”
Basic Safety

2nd Edition: Regulatory > Safety > Quality > Functionality

3rd Edition: Basic Safety and Essential Performance

BASIC SAFETY is freedom from unacceptable RISK directly caused by

physical HAZARDS when ME EQUIPMENT is used under NORMAL
CONDITION and SINGLE FAULT CONDITION.
Essential Performance and Operating Conditions
ESSENTIAL PERFORMANCE (EP) is defined as performance
necessary to achieve freedom from unacceptable RISK.

Essential performance (EP) and operating conditions should be

defined and detailed fault analysis should be provided ahead of
investigation.

Faults are divided into 3 probability categories:

• so remote that they can be ignored (e.g. REINFORCED INSULATION, TENSILE

SAFETY FACTOR of 8X, COMPONENT WITH HIGH-INTEGRITY
CHARACTERISTICS)

• probable enough that they need to be considered, but improbable enough that
they need only be considered one at a time (SINGLE FAULT)

• so likely, so unpredictable or undetectable that they are considered to be a

NORMAL CONDITION and need to be considered individually and collectively
(“WORST CASE”).
WORST CASE or SINGLE FAULT?
Until now, two or more independent faults were considered so unlikely
that only “single-fault” issues need be considered

Where the probability of multiple faults is high enough (e.g., due to

water spillage, inadequate design for ageing or corrosion), then two or
more independent faults could occur with sufficient likelihood and
can even be considered “WORST CASE” of NORMAL OPERATION.

General rule is failure of anything less than one MOP (means of

protection) is considered NORMAL OPERATION
MOP
The reliability of components that are used as MOP shall be assessed
for the conditions of use in the product. They shall comply with one of
the following :

• the applicable safety requirements of a relevant IEC, ISO or

national standard;
• where there is no relevant IEC or ISO standard, the requirements
of this standard have to be applied.

Example: Gaskets and Seals shall comply to IEC60950-22,

National Standards UL50E and UL 157

Testing for IP protection without gaskets if gaskets are not approved.

RISK MATRIX
RISK is combination of the probability of occurrence of HARM and the
severity of that HARM

Severity
Probability Serious Moderate Minor Not relevant
High High High Medium No Risk
High High Medium Low No Risk
No Risk

Not relevant

Risk can be acceptable (e.g. green area) or unacceptable (red).

EP for products with alarm conditions
If MD needs to notify the OPERATOR that a HAZARDOUS SITUATION can exist,
then MD “shall include an ALARM SYSTEM complying with this collateral
standard for that purpose.”

The definition of ALARM CONDITION is

“state of the ALARM SYSTEM when it has determined that a potential or actual
HAZARD exists”.

If you determined that such state exists, then EN / IEC 60601-1-8 is applicable.
Alarm Signals
… and if applicable, you need to generate visual signal as specified below.

6.3 Generation of ALARM SIGNALS

6.3.1 General
Each ALARM CONDITION shall cause the generation of visual ALARM SIGNALS
as specified in this collateral standard.

If deemed necessary by RISK ASSESSMENT regarding the environment in which the

ALARM SYSTEM is intended to be used, additional ALARM SIGNALS shall be
generated. These additional ALARM SIGNALS may be auditory, verbal, vibratory or
produced by other means.

Please note the requirements of IEC 60601-1-8 standard relevant also to sound
messages to patient (sound level, bandwidth and the like).
IEC 60601-1 3rd Edition: Why NOT to do it now?
Technical:

• Do not comply with 3rd Edition.

• Particular standard exist only for 2rd Edition
(e.g. Part 2-24: Particular requirements for the safety of infusion
pumps and controllers IEC 60601-2-24:1998).

Logistics:

• Many markets still do not accept 3rd Edition

• In most cases of particular standards, your product will become
“clinical trial” for test methods.
• Major issue can arise which will take much time to get resolved.
• Regulatory Managers have to perform integration between
various subjects and disciplines to get the approval.
IEC 60601-1 3rd Edition in May 2011

People Who Hate Me Don't Know Me

Today at HL leading industry experts will

present various disciplines which became
part of IEC60601 3rd Edition.
IEC 60601-1 3rd Edition: Why to do it now?
Technical reasons:

• Product introduction is only expected in 2012

• Product does not comply with 2nd Edition, or may provide
significant savings by complying to 3rd Edition.
• Particular or collateral standards exist only for 3rd Edition, e.g.
ECG and Home Healthcare products.

http://www.uluniversity.us/Content/73/MediaLibrary/Home_Healthcare_Whitepaper.pdf

Logistics:

• General tendency for complicating existing requirements and

adding new ones - it may be easier to get Certificate to 3rd Edition
now than in June 2012.
• After this seminar we all will know 3rd Ed. better - so it will be
easier to put all puzzle together,

OR...
IEC 60601-1 3rd Edition in 2012
Those who don’t love me
do not deserve to live

From this very practical point applicable at least

to European Market starting June 1, 2012…
we should start preparing ourselves for 3rd
Edition.
Conclusions, Part I
For some MDs, compliance to 3rd Edition is now the only option to
obtain regulatory approval!

Various national regulators accept 3rd Edition, and have already

announced withdraw date for 2nd Edition.

For various product categories, regulatory assessment becomes

state-of-the-art multidiscipline project with major time and cost
implications.

Always review your contract with test lab to understand SOW.

With 3rd Edition, it is not only Certificate of Compliance, but also Test
Report and its content!
Risk Management File
The manufacturer shall define essential performance and compile
documentation on known and foreseeable hazards associated with
the MD in both normal and fault conditions.

Reasonably foreseeable sequences or combinations of events that

can result in a hazardous situation shall be considered and the
resulting hazardous situation(s) shall be recorded.

For each identified hazardous situation, the associated risk(s) shall be

estimated using available information or data.

For each identified hazardous situation, the manufacturer shall

decide, using the criteria defined in the risk management plan, if risk
reduction is required.

The results of these activities shall be recorded in the risk

management file.
Essential performance: Table 1
4.3 TABLE: ESSENTIAL PERFORMANCE
List of ESSENTIAL MANUFACTURER’S document number reference or reference REMARKS
PERFORMANCE from this standard or collateral or particular standard(s)
functions

Supplementary Information:
ESSENTIAL PERFORMANCE is performance, the absence or degradation of which, would result in an
unacceptable risk.
Essential performance: Table 2
There are more than 100 times where 3rd Edition requires to determine risk
acceptability in applying a particular requirement.

Latest TRF developed by IECEE has full matrix form for these clauses
(relevant requirements of ISO 14971 per requirement of IEC 60601-1 3rd Ed.

4.3
Clause of Document Ref. in RMF Result - Remarks Verdict
ISO (Document No. &
14971 paragraph)
4.2
4.3
4.4
5
6.4
Working with Risk Management File

Test Laboratory shall verify compliance

on a product basis and fill in the
checklist in the Technical Report Form
(TRF).
Risk management process
4.2

Clause of Document Ref. in RMF Result - Remarks Verdict

ISO 14971 (Document No. & paragraph)
3.3a
3.5e
4.1
4.2
4.3
4.4
5
6.1
6.2
6.3
6.4
6.5
6.6
6.7
7
Equivalent safety for ME equipment
Where the standard specifies requirements addressing particular
risks, alternative means of addressing these risks are acceptable

When relevant, Manufacturer must justify that the Residual Risks

that result from applying the alternative means are equal to or less
than the Residual Risks that result from applying the requirements of
this standard, and fill in the table below.
4.5

Clause Document Ref. in RMF Result - Remarks Verdict

of ISO (Document No. &
14971 paragraph)
4.2
4.3
4.4
5
6.4
Parts that can come into contact with patient
All parts that can come into contact with patient but not defined
as applied parts are subjected to the requirements for B type
applied parts as per clause 8.3d) .

Probability of occurrence and duration of contact for parts likely

to be touched and for applied parts shall be documented in risk
management file.
4.6

Clause of Document Ref. in RMF Result - Remarks Verdict

ISO (Document No. &
14971 paragraph)
4.2
4.3
4.4
5
6.1
6.2
6.3
6.4
6.5
6.6
Single Fault Condition
4.7 ! " #
Clause of Document Ref. in RMF Result - Remarks Verdict
ISO 14971 (Document No. & paragraph)

4.2

4.3

4.4

6.1

6.2

6.3

6.4

6.5

6.6
Components of ME equipment
All components, including wiring, the failure of which could result
in a hazardous situation shall be used in accordance with their
specified ratings, unless a specific exception is made through
the Risk Management Process (RMP).
4.8 "
Clause Document Ref. in RMF Result - Remarks Verdict
of ISO (Document No. &
14971 paragraph)
4.2
4.3
4.4
5
6.1
6.2
6.3
6.4
6.5
6.6
Components with high-integrity characteristics
A component with high-integrity characteristics shall be used when a
fault in a particular component can generate an unacceptable RISK.

Components with high-integrity characteristics shall be selected and

evaluated consistent with their conditions of use and reasonably
foreseeable misuse during the expected service life of the MD.
4.9 $ %
Clause of Document Ref. in RMF Result - Remarks Verdict
ISO 14971 (Document No. & paragraph)
4.2
4.3
4.4
5
6.1
6.2
6.3
6.4
6.5
6.6
Alarm systems as a means of risk control
Address in the risk management process the need for alarm
systems as a means of risk control and address any risks
associated with the operation or failure of the alarm system.

See IEC 60601-1-8, and fill in relevant table in TRF.

12.3
Clause of Document Ref. in RMF Result - Remarks Verdict
ISO 14971 (Document No. & paragraph)
4.2
4.3
4.4
5
6.1
6.2
6.3
6.4
6.5
6.6
Operation of overcurrent or thermal protection
Evaluation that loss of function of ME equipment by power
interruption and restoration (e.g. due to operation of thermal cut-
out or over current release) does not provide unacceptable risk in
the end system.

Subclause 11.8 – Interruption of the power supply / supply mains.

Interruption of the power supply could result in a hazard due to
loss of functionality.

Restoration of the power source can also result in hazardous

situations.

15.4.2.1 d
Clause of Document Ref. in RMF Result - Remarks Verdict
ISO 14971 (Document No. & paragraph)
4.2
4.3
4.4
Conclusions, Part II

What needs to be done to minimize assessment time?

The clauses of ISO 14971 shall be addressed in RMF.

Best option to fill in IECEE TRF of IEC60601-1 3rd Ed. template. Other
formats can be used, but assessment may require much more effort.
Aspects of Accreditation related to MD approvals

• Home Healthcare as example of approval integration

challenge

• How to work with GLP accredited contractors.

Finding right balance
Compliance with a standard offers a very good claim that the product
was indeed safe, but …

as the British Standards Institute states in the preamble to all its type
test standards,

“compliance with a British Standard does not of itself confer immunity

from legal obligations”.

1. Use a Good Practice: GMP/GLP/GCP and the like.

2. Make your own Project Risk Assessment and Risk Mitigation Plan
3. Subcontract work to accredited 3rd party laboratories
4. Use Notified Body to approve complete package
Home Healthcare
IEC 60601-1-11:2010 is the newest Collateral Standard to the 3rd
Edition. Published in April as IEC and already a MUST for MDD.

Title: Medical electrical equipment – Part 1-11: General requirements

for basic safety and essential performance – Collateral Standard:
Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment

Good presentation by Dave Osborn, Philips Healthcare Sector Standards and

Regulations Secretary, JWG6-Home Healthcare

http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM214274.pdf
Home Healthcare Environment
Any environment that is NOT a professional healthcare facility
(where OPERATORS with medical training are continually available).

NO PROTECTIVE EARTH connection only floating type applied parts

permitted, unless the equipment is permanently installed by an
electrician.

Equipment intended for the home healthcare environment must be

Class B with respect to emissions.

The usability evaluation is required.

ENCLOSURES must be at least IP21 (light rain proof).

TRANSIT-OPERABLE, HANDHELD, and BODY-WORN equipment

must be at least IP22.

Do not seal battery compartments!

International Approvals for Home Healthcare
Before IEC 60601-1-11 manufacturers of healthcare equipment intended
for use in homes have been required to comply with

Europe: EN60335-1 with particular standards

N. America: UL60601-1 or UL1431
ROW: IEC60335-1 or IEC 60601-1

After IEC 60601-1-11 which covers most home healthcare equipment,

some devices may still be subject to the requirements of other
standards.

For example, UL1431 “Personal Hygiene and Health Care Appliances” covers
household electric products for hygiene or other healthcare applications rated at
250 V or less. Products covered under this standard include hydromassage
units, nebulizers, breast pumps, toothbrushes and contact lens disinfectors.

Europe: EN60601-1 3rd Ed. With EN60601-1-11

N. America: ANSI60601-1 with IEC60601-1-11, or UL1431
ROW: IEC60335-1 or IEC 60601-1 2nd Ed
Required accreditation level
Most certification bodies accept manufacturer internal verification. In
this case, no accreditation at all or GLP is acceptable.

For US and Canada, NRTL will most probably require NRTL level for all
Reports including collateral standards (EMC, SW validation, and
usability), or offer “Evaluation” service, not Listing.

Biocompatibility and physiological effects are always excluded by NRTL.

International Approvals: CB scheme
CB Scheme proved itself as most reputable.

Also, governmental bodies act as NCBs in CB Scheme and as such

have to accept CB test reports.

Non – IEC issues are excluded

Non-medical electrical equipment
One of the most advertised technical changes in 3rd Edition is the
relaxation of operator protection requirements, which makes for
significant savings on the cost of medical equipment.

For example, if a device or its components do not touch the patient,

then that device or its components only need to meet the less
stringent insulation and leakage requirements of IEC 60950-1 (ITE).

What about EMC? Most probably, ITE device or its components do

not comply with immunity requirements of MD.
Normative references
Always has been and still remains a problem!

2nd Ed: Particular standards may be synchronized with withdrawn

collateral standard, like IEC60601-2-24:1996 (still in force) is based
on IEC60601-1-2:1993.

3rd Ed: “The following referenced documents are indispensable for

the application of this document. For dated references, only the
edition cited applies. For undated references, the latest edition
of the referenced document (including any amendments) applies.”
IEC 60950-1:2001, Information technology equipment – Safety – Part 1: General requirements

IEC 60825-1:1993, Safety of laser products – Part 1: Equipment classification, requirements and
user's guide, with Amendment 1 (1997) and Amendment 2 (2001)
Conclusions, Part III
System approach has always been required, but 3rd Edition put more
stress on it as number of disciplines required to be integrated into
regulatory approval has greatly increased.

You need to understand your product market to make proper

selection of sub-contractors and provide expected level of
accreditation.

Major aspects of essential performance and risk management are

not synchronized between various regulators and test labs. Non-
electrical disciplines are not synchronized at all.
Q&A

Thank You!