IEC 60601-1:2005,

AMENDMENT 2: 2020
An overview

Claudia Sirch, Chief Engineer, Global Engineering

Clarissa Benfield, Global Key Account Executive

DECEMBER 2020
IEC 60601-1:2005, AMD2:2020

01 Intertek Overview

02 IEC 60601-1 Ed.3 Introduction

03 Changes in this development cycle – an overview

04 The changes in IEC 60601-1 Ed.3 Amendment 2

05 Questions

2
01
INTERTEK OVERVIEW
 Intertek has always been
a pioneer, anticipating the
needs of its clients with
bold innovations ahead
of its competitors.
True to the spirit of our founders, we’re
leading the industry with our Total Quality
Assurance (TQA) value proposition –
going beyond physical quality control through
our Testing, Inspection and Certification services –
to offering Assurance services, ensuring our
customers’ operating procedures and systems
are functioning properly.

4
© Intertek Group
WE ARE UNIQUELY POSITIONED TO DELIVER ATIC SOLUTIONS WITH OUR
GLOBAL NETWORK

45,000+ 100+
employees countries

Global Market
Global Market
Leader in
Leader in TIC
Assurance

3,000 1,000+
auditors labs and offices

90,000+ 80+
audits languages
Assurance | Testing | Inspection | Certification

5
Systemic approach to Quality 5
and Safety with ATIC Solutions
6
7
02
IEC 60601-1 ED.3
INTRODUCTION
IEC 60601-1:2005 (EDITION 3) - INTRODUCTION

IEC 60601-1 covers general requirements for basic safety and essential
performance of medical electrical equipment and medical electrical
systems. The third edition of the standard was published in 2005, with
the first amendment issued in 2013.

Now the second amendment of the standard has been being published
and various collateral standards have been updated to align with this
amendment. It includes various changes and clarifications manufacturers
need to be aware of.

9
IEC 60601-1:2005 + AMD1:2012 + AMENDMENT 2:2020
Collateral standards Part 1-1
General standard IEC 60601-1-XX
• To be used together with Part 1
(Part 1 standard) • Part 1 is not fulfilled if not all applicable collaterals are used

IEC 60601-1
60601-1-2 60601-1-3 60601-1-X

(Part 2)
60601-2-1
Particular
60601-2-2
standards
60601-2-4
IEC 60601-2-XX Amendments
60601-2-12
IEC 80601-2-XX
ISO 80601-2-XX 60601-2-xx
Examples: CTL Decision sheets
60601-2-4 Cardiac defibrillators
60601-2-18 Endoscopic equipment 10
60601-2-52 Medical beds
03
CHANGES IN THIS
DEVELOPMENT
CYCLE – AN
OVERVIEW
IEC 60601-1:2005 (EDITION 3) – AMENDMENT 2

The items addressed in the second amendment were flagged in

response to industry input after working with the standard’s third
edition and its first amendment. These concerns were short-listed for
immediate attention and addressed in Amendment 2. The work started
in late 2016 and ended with the publication for industry in August 2020.

Amendment 2 improves and further develops requirements of the

previous version by updating outdated references, providing more
definitions and correcting or clarifying technical issues.

This presentation gives an overview on the changes with focus on

selected requirements which most likely may have an impact on existing
or future designs, and/or are applicable for a broad range of products.
12
IEC 60601-1:2005 (EDITION 3) – AMENDMENT 2
A lot of changes seem to be minor
however, previously certified
devices may not automatically
meet the requirements of
Amendment 2.
Thus, manufacturers should
consider Amendment 2
requirements in new designs even
though transition times of 3+
years can be expected before the
national versions of the standard
become mandatory in the target
countries.
Summary of main IEC 60601-1 clauses affected by changes in AMD2
3 Terms and definitions Updated terms and definitions
7 Identification, marking,
(alignment with ISO 14971:2019)
Changes to the requirements for safety
documents signs, IP classification, batteries, power
switches, colors of indicator lights
8 Protection against Changes/clarifications to the
electrical hazards requirements for touch currents, means
of protection including creepage
distances / clearances, max. mains
voltage, working voltage, defibrillation
protection and energy reduction, mains
fuses/overcurrent releases
9 Protection against
mechanical hazards
Changes/clarifications to requirements
for pressure vessels and parts subject to
pressure, and to support systems (tensile
safety factor, dynamic forces due to
loading from persons)
11 Protection against
excessive temperatures
Changes to constructional requirements
for fire enclosures
and other hazards
13 Hazardous situations and New table added for temperature limits
fault conditions of accessible parts likely to be touched
but not intended to be touched for
equipment operation
REVISED COLLATERAL STANDARDS
Some items on the ‘short list’ related to the collateral standards
which have been updated as following:
Collateral standards aligned with IEC 60601-1 Ed.3+AMD1+AMD2:
IEC 60601-1-2 Ed.4 + AMD1 Electromagnetic disturbances – Requirements and tests

IEC 60601-1-6 Ed.3 + AMD1 + AMD2 Usability

IEC 60601-1-8 Ed.2 + AMD1 + AMD2 General requirements, tests and guidance for alarm
systems
IEC 60601-1-9 Ed.1 + AMD1 + AMD2 Environmentally conscious design (admin update only)

IEC 60601-1-10 Ed.1 + AMD1 + AMD2 Development of physiologic closed-loop controllers

IEC 60601-1-11 Ed.2 + AMD1
IEC 60601-1-12 Ed.1 + AMD1
Medical electrical equipment and medical electrical
systems used in the home healthcare environment
Medical electrical equipment and medical electrical
systems intended for use in the emergency medical
services environment (admin update only)
14
RELATED STANDARDS UPDATED IN THIS DEVELOPMENT CYCLE

Standard Title
ISO 14971:2019 Medical devices – Application of risk
management to medical devices
IEC 62366-1:2015 AMD1:2020 Medical devices – Part 1: Application of
usability engineering to medical
devices
IEC 62304:2006+AMD1:2015 Health software - Software life cycle
processes
(Forecast publication date for Ed.2: 2021-
10)

15
IEC 60601-1:2005 (EDITION 3) – AMENDMENT 2

Other concerns, which were not considered to be as high of a priority,

were added to a “long list” and will be addressed later in the 4th edition of
the standard. This is not expected prior to 2027.

As such, the changes and revisions of the second amendment will mark
the standard to be used in medical devices for several years to come.

It is critically important for manufacturers to know and understand the

latest edition, its changes and the standard as a whole in order to ensure
timely, cost-effective, and successful product development and launches.

16
04
THE CHANGES IN
IEC 60601-1 ED.3
AMENDMENT 2
CLAUSE 2 NORMATIVE REFERENCES
Some normative references in Clause 2 have been updated or added. This is
important to remember as this, in some cases, may have a major impact on products
whenever the (updated) standard versions include significant technical changes.
Examples of updated standards include the following:

• The latest dated versions of collateral standards IEC 60601-1-2 (EMC), -1-3
(Radiation protection in diagnostic X-ray equipment), -1-6 (Usability) and -1-8
(Alarms) are being referenced (60601-1-8 includes some significant changes)
• Standard versions have been updated for IEC 60825-1 (Laser products), IEC 60950-
1 (Information technology equipment), IEC 62304 (Medical device software –
software life cycle processes) and ISO 14971 (Risk management)
• An undated reference to IEC 62133-2 (Lithium batteries) and a reference to the
2018 version of IEC 62368-1 (Audio/video, information and communication
technology equipment) have been added
The standard versions have also been updated in other clauses such as in 10.4 where
the reference to the laser standard was updated from the IEC 60825-1:2007 to the
2014 version. 18
NORMATIVE REFERENCES REVISED IN OTHER CLAUSES – COLLATERAL AND
PROCESS STANDARDS
Cl. 4.2 Risk Management Process
• ISO 14971:2019
Cl. 12.2 Usability
• IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013 and IEC 60601-1-
6:2010/AMD2:2020.
Cl. 12.3 Alarm Systems
• IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-
8:2006/AMD2:2020.
Cl. 14 Programmable Electrical Medical Systems (PEMS)
• IEC 62304:2006 with IEC 62304:2006/AMD1:2015
Cl. 17 Electromagnetic compatibility
• IEC 60601-1-2:2014 and IEC 60601-1:2014/AMD1:2020.
• RISK(S) associated with ELECTROMAGNETIC DISTURBANCES SHALL BE ADDRESSED 19
CLAUSE 3 TERMINOLOGY AND DEFINITIONS
Terms which have been
aligned(some with modification)
with ISO 14971:2019
• 3.38 HARM
• 3.40 HAZARDOUS SITUATION
• 3.44 INTENDED USE /
PURPOSE
• 3.55 MANUFACTURER
• 3.89 PROCESS
• 3.100 RESIDUAL RISK
• 3.107 RISK MANAGEMENT
Terms which have been aligned
(some with modification) with
IEC 62366-1
• 3.136 USABILITY
• 3.137 USABILITY
ENGINEERING
• 3.138 VERIFICATION
• 3.146 PRIMARY OPERATING
FUNCTION
• 3.147 USABILITY
ENGINEERING FILE
Terms which have been
added and aligned (some
with modifications) with IEC
60601-1-8:2006+AMD2:2020
• 3.149 HIGH PRIORITY
• 3.150 INFORMATION
SIGNAL
• 3.151 LOW PRIORITY
• 3.153 MEDIUM PRIORITY

• 3.148 ELECTROMAGNETIC DISTURBANCE

• 3.152 MAXIMUM EQUIPMENT PRESSURE
• 3.154 SAFETY SIGN
20
CLAUSE 7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTS
Amendment 2 clarifies in 7.4 that the use of the ‘refer to instruction
manual/booklet mandatory action safety sign’, symbol 10* is required
• When the manufacturers uses this as a primary risk control measure for a
specific risk (e.g. if the instructions for use contain information for safety), AND
• The usability engineering process determines that marking the equipment is
required for the effectiveness of the risk control.

Various additional markings options are given for switches:

• For a switch to control power to parts of the equipment: Symbols 16/17*,
indication by adjacent indicator light or other unambiguous means; a ‘stand-
by’ condition switch may be indicated by symbol 29*.

The existing table showing the indicator lights and their meaning was
replaced with a new one which includes requirements from IEC 60601-1-8.

*Source: IEC 60601-1:2005+AMD1:2012+AMD2:2020, Annex D 21

CLAUSE 8 PROTECTION AGAINST ELECTRICAL HAZARDS: LIMITATION OF
VOLTAGE, CURRENT OR ENERGY (8.4)
Accessible parts and
applied parts - parts not
likely to connect to patient
through operator:
A test procedure was
added for equipment which
has SIP/SOP* or separate
power supply output
connectors from the
accessible, conductive
connectors of such parts to
earth.
*SIP/SOP: Signal input/output
• Measuring device –
Voltmeter or
Oscilloscope
• Resistance used in the
circuit
10 kΩ ± 500 Ω (8 W
for measurements up
to 280 V r.m.s.)
If the measured voltage to earth exceeds 60 V d.c. or
42,4 V peak a.c. in normal and single fault condition:
The mains derived touch current has to be measured**.
**Normal and single fault condition:
• NORMAL CONDITION, including open functional earth (if applicable)
• SINGLE FAULT CONDITION, respectively open neutral conductor;
open PROTECTIVE EARTH CONDUCTOR (if applicable)
Otherwise, leakage current test not required
22
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
MOOP OR MOPP (8.5)?
MOP = Means Of Protection
MOOP = Means Of Operator Protection
MOPP = Means Of Patient Protection
MEE = Medical Electrical Equipment

The second paragraph in the text in the ‘General’ section for MOPs was re-written for better
understanding and (informative) Figure A.12 (MOP selection flowchart) included in the
mandatory part of the standard as figure 40.
It is now made clear that each MOP shall be categorized in relation to the MEE part(s) which
it protects from exceeding permitted limits.
It is a MOPP if it protects applied parts, or parts that are identified according to 4.6 as
needing to be subject to the same requirements as applied parts.
Otherwise the requirements for either MOPP or MOOP shall be used as shown in Figure 40.
23
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
MOOP OR MOPP (8.5)?
For Operator
In various clauses Figure 40* Protection (MOOP):
throughout section 8
Use any of the
references to IEC possible
62368-1 were added requirements (from
where references to IEC 60601-1, or IEC
IEC 60950-1 already 60950-1 or IEC
existed. 62368-1.

In some cases there This means:

are specific
requirements when IEC 62368-1 can be
IEC 62368-1 is used for
used directly as an
alternative to IEC
isolation coordination,
60950-1.
e.g. for spacings,
8.9.1.2.
24
*Source: IEC 60601-1:2005+AMD1:2012+AMD2:2020
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
ACCEPTANCE OF IEC 62368-1

IEC 62368-1 specifies the safety requirements of audio/video,

information and communication technology equipment – Part 1: Safety
requirements.
This standard is replacing IEC 60950-1 (and IEC 60065), which is no
longer being maintained. This will eventually lead to the lack of
components on the market which comply with IEC 60950-1.
IEC 62368-1:2018 can be used as a MOOP for insulation coordination
(spacings, dielectric strength) and protective earthing, but NOT
automatically as a MOPP. For MOPP, considerations can arise as a result
of the risk management process.

25
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
ACCEPTANCE OF IEC 62368-1
IEC 60601-1 AMD2 notes,
flowcharts, and calculations
based on specific
parameters representing Figure A.26*:
‘real-life scenarios’ in the How to
main text of the standard determine air
and informative Annex A clearance
help manufacturers in their requirements in
process to determine if a IEC 62368-1
62368-1 compliant MOP is (excerpt from IEC
acceptable for use in the TR 62368-2:
IEC 60601-1 end use
application. Examples
include the following:

*Source: IEC 60601-1:2005+AMD1:2012+AMD2:2020 26

PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
ACCEPTANCE OF IEC 62368-1
Further examples of guidance and requirements regarding the use of IEC 62368-1 for MOP:
Note 2 in 8.1.5.2 (MOPP):
Barriers providing reinforced
insulation (2 MOOP) with air
clearance values according to IEC
62368-1:2018 for working
voltages up to and including 354 V
d.c. / 250 V r.m.s. meets the
requirements for 1 MOPP
according to Table 12. At higher
working voltages, reinforced
insulation (2 MOOP) does not
necessarily provide 1 MOPP.
Note 3 underneath Table 6
(Dielectric strength)
Insulation meeting the requirements
for the test voltage for reinforced
insulation for a nominal mains
system voltage up to and including
250V r.m.s according to IEC 62368-
1:2018, Table 27 meets the
requirements for 1 MOPP according
to this table for a peak working
voltage up to 1293 V. At higher
working voltages the insulation
does not necessarily provide 1
MOPP.
Note 4 2nd paragraph
underneath Table 12 (cr/cl
providing MOPP)
Barriers providing reinforced
insulation (2 MOOP) according to
IEC 62368-1:2018 meet the
requirements for
1 MOPP for working voltages up to
and including 354 V d.c. / 250 V
r.m.s. according to this table. At
higher working voltages, reinforced
insulation(2 MOOP) does not
necessarily provide 1 MOPP.

8.9.1.2 Creepage Distances and air clearances: Equipment/sub-assemblies/components complying with IEC 62368-
1:2018 designed specifically for use with transient-free supply mains shall additionally comply with the applicable 27
requirements of Table 13 to Table 16 (inclusive).
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
ACCEPTANCE OF IEC 62368-1: USE SCENARIOS
Scenario Description Examples
Equipment complying with IEC 62368-1:2018 is built Internal power
into MEE. In this scenario, equipment complying with supplies,
IEC 62368-1:2018 is fully contained within the optical-isolator,
enclosure of the MEE and is accessible only with the transformers,
use of a tool (the output parts of the power supply or processor board
ac-dc connectors may be accessible at SIP/SOP assemblies,
connections without the use of a tool). Equipment dc-dc converters, ac-
complying with IEC 62368-1:2018 is generally dc converters,
*Source of images: considered as a component/part of the MEE and they Bluetooth
IEC 60601-1:2005+AMD1:2012+AMD2:2020
cannot be used separately. communication
modules
Equipment complying with IEC 62368-1:2018 is External/Stand-alone
provided as a part of MEE but is not built into MEE power supplies,
and is readily accessible to the operator and/or computers, monitors,
patient. Equipment complying with IEC 62368-1:2018 printers, keyboards
is provided with its own enclosure and may be used
separately from the MEE.
28
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
ACCEPTANCE OF IEC 62368-1
To summarize: With AMD2, the application of the insulation coordination requirements in
IEC 62368-1:2018 can be used as a MOOP for subassemblies/components that are built
into MEE. However,
1. In all cases, the requirements for MOPP in this standard still need to be applied /
evaluated (with IEC 60601-1 AMD2 providing guidance), and
2. It is important to remember that not all requirements for operator protection in IEC
62368-1:2018 have been integrated in AMD2 – only Clause 8 and one note in Clause 10
have been addressed. For the remainder of IEC 60601-1, the safety solutions in IEC
62368-1:2018 have not been considered in AMD2 (will be addressed during the
development IEC 60601-1 Ed.4).
For IEC 62368-1:2018 certified sub-assemblies/components built into MEE, Clause 7 and
Clauses 9 to 15 (inclusive) of IEC 60601-1 are applied as stated. If a requirement in IEC
62368-1:2018 is related to operator safety and conflicts with parts of Clause 7 and Clauses
9 to 15 (inclusive), it can be evaluated according to the detailed requirements of 4.5.
29
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
Y-CAPS AND OPTICAL ISOLATORS (8.5)
A new note 3 in 8.5.1.2 helps manufacturers determine suitability of y-caps bridging
MOPP regarding dielectric strength for the following ‚typical‘ voltage ranges:
• For voltages in the range of 212 V peak (150 V rms) to 354 V peak (250 Vrms), Two Y1 capacitors for 2
MOPP (Y1 dielectric strength rated 2500 V a.c.; 2MOPP require 4000 V a.c)
• For voltages below 212 V peak (150 V rms), two Y2 capacitors for 2MOPP, (Y2 dielectric strength rated
1500V a.c.; 2MOPP dielectric strength require 3 000 V a.c)

New requirements for opto-coupler in Cl. 8.5.1.2 & 8.5.1.3 (MOPP & MOPP):
Opto-couplers complying with IEC 60747-5-5:2007, or a later edition, are considered
equivalent to the requirements of 8.8.2 (solid insulation) and 8.9.3 (thermal cycling).
• The following applies: Air clearance and creepage distance at the outside of the
opto-coupler, and dielectric strength across the opto-coupler
The factor of 1.6 on insulation test voltage for thermal cycling tests (8.9.3) is not required as IEC 60747-
54-5 applies different test methods. Distance Through Insulation (0.4mm) and thermal cycling testing
are not required as compliance with the component standard addresses the risk of pin holes and
thermal effects on the insulating compound. 30
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
WORKING VOLTAGE (8.5.3, 8.5.4)
Additional text was added clarifying how the working voltages shall be measured, and
the maximum mains voltage was changed from 250V to 240V.

The working voltage is determined by

inspection, calculation or measurement.
For working voltage measurement, all circuits
shall be connected to earth except for floating
parts providing at least one means of
protection to earth in which case take the
highest measured voltage of either side of the
barrier.
*Source: IEC 60601-1:2005+AMD1:2012+AMD2:2020 (NEW) Figure 41*

For Case 1, the floating circuit is isolated by 1 MOP to earth based on the floating circuit voltage U2. The working voltage
(Uw) of the mains barrier is the highest voltage of one side of the barrier, i.e. U1 or U2 whichever is greater in magnitude

for Case 2, the floating circuit is not isolated by at least 1 MOP to earth based on the floating circuit voltage U2. For the
31
measurement of Uw of the mains barrier both sides have to be earthed to obtain repeatable worst-case results
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
PROTECTIVE EARTH IMPEDANCE (8.6.4)
The test requirement for using a 3 m long detachable power cord if not supplied or
specified was removed. It now states that for ME Equipment powered from detachable
power cord, testing shall be carried out using a detachable power supply cord as
provided or specified (length and cross-sectional area) by the manufacturer.

Clarification has been added

what the highest rated
current is that is the basis to
determine the test current for
the impedance test (=25 A or
1.5x rated current of the
relevant circuit) – which
depends on the location of
the prospective fault.
• The highest rated current is the rated current of the over-current
protection in the MEE when present, for all circuits located behind the
over-current protection.
• From the supply mains to the over-current protection in the MEE, the
highest rated current is the rated current of the over-current protection
device in the building installation. 32
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
LEAKAGE CURRENTS AND PATIENT AUXILIARY CURRENTS
Previously no details were provided for the
measuring device for the measurements as per
8.7.3e). AMD2 clarifies that such a device shall be
similar to that shown in Figure 12a)* but without C1
and R1.

For measuring supply circuits (8.7.4.2) there were no drawings in

the standard showing the test setup for internally powered MEE,
therefore leakage current measurements for battery powered
devices were often missed, or it was unclear how to conduct the
testing. AMD2 clarifies that internally powered equipment is tested
without any connection to a measuring supply circuit: Figure 14 to
Figure 20 (inclusive) do not use the isolation transformers T1 or
switches S1 and S5.
33
Example: Figure 15* patient leakage current test setup *Source: IEC 60601-1:2005+AMD1:2012+AMD2:2020
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
DIELECTRIC STRENGTH / CREEPAGE DISTANCES & AIR CLEARANCES
Errors were corrected:
• Table 6 (test voltages for solid insulation forming a MOP): the working voltage range 10, 000 < U < 14,140,
The testing voltage for MOOP should be 1.06 x U instead of 1.06 × U / 2
• For creepage distances and air clearances, in various paragraphs of 8.9.2, 8.9.4 and Figure 23, ‘less than
1mm’ was corrected to ‘less than X mm’ (X depends on various factors including pollution degree)

Various notes have been added underneath Table 12 (cr/cl providing MOPP) with
clarifications such as:
• the values being applied regardless of pollution degree, over-voltage category and material group
• the creepage distance and air clearance are both related to r.m.s. or d.c. working voltages
• the values do not take into account waveforms with low r.m.s. and high peak working voltages (for Switch
Mode Power Supply Units use the measured r.m.s. as the working voltage).

A new subclause 8.9.1.16 has been added to address conductive surface coatings applied to
non-metallic surfaces where it shall be established that flaking or peeling does not result in
the reduction of any are clearance or creepage distance, with the note giving examples of
coating test standards including UL746C. 34
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT:
POWER SUPPLY CORD CONDUCTORS, MAINS FUSES/OVERCURRENT
RELEASES (8.11)
To determine the required cross-sectional area of power supply cord conductors
operating at currents greater than 63 A, apply the electrical regulations appropriate
for the jurisdiction in which the MEE is to be used.

The note “If fuses complying with IEC 60127 are used and the prospective short-circuit
current exceeds 35 A or 10 times the current rating of the fuse, whichever is greater,
the fuses should have high breaking capacity (1 500 A)” was removed and replaced
with the following:
“Protective devices shall be of a breaking capacity based on the manufacturer’s
expectation of the highest branch circuit current and/or prospective short circuit
current”.

35
PROTECTION AGAINST MECHANICAL HAZARDS

Clause 9 includes some minor additions/clarifications only, including the following:

• A note in 9.6.2.1 (which specifies limits for audible acoustic energy), that acoustic
energy associated with the intended use of the MEE or MES is excluded
• Addition of text in Table 21 for determination of tensile safety factors for
mechanical protective devices specifying that for metallic materials a specific
elongation at break equal to or greater than 5% is assumed
• Clarification from where the mass is dropped (150mm from the lowest edge of the
foam) for the dynamic forces test

36
PROTECTION AGAINST UNWANTED AND EXCESSIVE RADIATION HAZARDS:
LASERS (10.4)
The text was revised to stress the fact that IEC 60825-1 applies for lasers including laser
diodes that produce or amplify electromagnetic radiation in the wavelength range from
180 nm to 1 mm.
As noted earlier, IEC 60825-1:2007 was replaced with IEC 60825-1:2014.

Notes:
• Manufacturers should be aware that for Class 3B and 4 medical laser products, IEC 60601-2-22 is
applicable.
• IEC 62471 gives guidance for evaluating the photobiological safety of lamps and lamp systems
including luminaires.
• IEC 60601-2-57 can be used in the risk management process for MEE incorporating non-laser light
sources intended to create non-visual photobiological effects (applies for therapeutic, diagnostic,
monitoring and cosmetic/aesthetic use)

37
PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER HAZARDS:
CONSTRUCTIONAL REQUIREMENTS FOR FIRE ENCLOSURES (11.3)
Some corrections were made, and additional requirements
added:
• The requirements for insulated wiring were reduced from
from V-1 to V-2
• As an alternative to having no openings in the sides of a
fire enclosure within the area that is included within the
inclined line C in Figure 39* on or the following designs
may be used:
o be made of metal, perforated as specified in Table 25
(includes requirements for max. diameter of holes and
max. spacing of holes centre to centre based on the
min. thickness); or
o be a metal screen with a mesh not exceeding
2 mm x 2 mm centre to centre and a wire diameter of Source: IEC 60601-1:2005+AMD1:2012+AMD2:2020
at least 0.45 mm.
38
PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER HAZARDS /
HAZARDOUS SITUATIONS AND FAULT CONDITIONS: MAXIMUM
TEMPERATURES (13.1.2)
A new Table 34 was added specifying limits for accessible parts that are likely to be
touched, but no intended to be touched to operate the MEE, when measured and
adjusted as required in 11.1.3. Accessible parts intended to be touched to operate the
MEE still shall comply with table 23.
1)values from Table 23.

ME EQUIPMENT and its Maximum temperature °C

Metal Glass, porcelain, Moulded material,
parts and liquids vitreous material plastic, rubber Wood
External surfaces of
ACCESSIBLE PARTS that are 80 90 104 150
likely to be touched for a (74)1) (80) 1) (86) 1) (86) 1)
time t < 1 s

39
HAZARDOUS SITUATIONS AND FAULT CONDITIONS: EMISSIONS,
DEFORMATION OF ENCLOSURE OR EXCEEDING MAX. TEMPERATURE (13.1.2)
Changes include a combination of revised text, added note and new compliance check
requirements for secondary circuits. (Current) requirements are summarized here with
changes highlighted.
Single fault with regard to the emission of flames, molten metal or ignitable substances,
related to fire hazards not required where:
• Circuit <15W (900J)
• Secondary circuit meeting the requirements on the next slide
• High-integrity characteristics component
• Completely contained within a fire enclosure

Added Note: When the investigated part of the supply circuit is a battery, the limit for the
power dissipation check directly on the output contacts of the battery, even before an external
protective device.
40
HAZARDOUS SITUATIONS AND FAULT CONDITIONS: EMISSIONS,
DEFORMATION OF ENCLOSURE OR EXCEEDING MAX. TEMPERATURE (13.1.2)

Secondary circuits do not Compliance is checked by the following:

require single fault testing if
they meet all the following:
• Mounted on V-1 material
• Voltage < 60 V d.c. or 42.4
(previously 42.2) Vpeak
• Circuit Limited to less than
100VA or less than 6000 J in
single fault condition
• Wiring insulation of type PVC,
TFE, PTFE, FEP,
polychloroprene or
polybromide
• drawing 100 VA from the supply circuit for
5 s after application of the load if
protection is by an electronic circuit
• drawing 100 VA from the supply circuit for
60 s for a positive temperature coefficient
device, or in other cases.
If, after the specified time above, drawing
less than 100 VA => limited power
dissipation (also review related design
documentation)

41
HAZARDOUS SITUATIONS AND FAULT CONDITIONS: SINGLE FAULT
CONDITIONS (13.2.1)

A new requirement was added:

If resistance to heat for insulation of thermoplastic materials that is

used as a supplementary or reinforced insulation is established by
a ball pressure test in 8.8.4.1, the test is performed at a
temperature 25 °C higher than the temperature of the insulation
measured during single fault test (13.2.2 to 13.2.13 inclusive)

42
CONSTRUCTION OF ME EQUIPMENT: LITHIUM BATTERIES (15.4.3.4),
TRANSFORMERS (15.5.3)

Secondary Lithium battery shall comply with the requirements of IEC 62133
or (NEW) IEC 62133-2.

New text was added to Annex A, Subclause 15.5.3 (construction of

transformers used to provide separation as required by 8.5) covering TIW
(triple-insulated winding wire) and FIW (fully insulated winding wire). It
explains that transformers complying with IEC 62368-1:2018 use FIW instead
of TIW but the use of FIW is deemed acceptable for MOOP only
The use of FIW as MOPP needs further investigation during the development
of Ed.4 before an alternative test method to comply with the requirements for
MOPP can be implemented in the normative text of Annex L.

43
ME SYSTEMS: PROTECTIVE EARTH CONNECTIONS IN ME SYSTEMS POWERED
FROM DETACHABLE POWER SUPPLY CORDS (16.9.2.2)
IEC 60601 requires for each part of a ME System that shares a supply mains connection,
to meet clause 8.6.4 for the impedance and current carrying capacity. Previously it was
required to measure the impedance between the PE pin in the mains plug and any part
that is protectively earthed. Now, this was modified to state:
Where the pathway of a fault current caused by a live part to a protectively earthed
part is protected only by the supply mains circuit over-current release (e.g. circuit
breaker or fuse), the protective earth resistance of that pathway shall not exceed 200
mΩ.

The following requirement was added:

Where the pathway of a fault current caused by a live part to a protectively earthed
part is protected by additional intermediate circuit breakers or fuses with current
ratings 13 A or lower, then compliance with 8.6.4 b) and 8.7.2, first dash, is achieved
and the protective earth resistance to that part of the fault pathway may exceed 200
mΩ but shall be less than 400 mΩ. 44
45
 Claudia Sirch
Chief Engineer – Medical,
laboratory, measurement, control
equipment and laser products
Regional Chief Engineer (EMEA)

Technical Questions contact claudia.sirch@intertek.com

Sales Inquiries contact icenter@Intertek.com

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