Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

Amendement 1 - Appareils électromédicaux - Partie 1-2: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Perturbations électromagnétiques - Exigences et essais

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Publication Date
31-Aug-2020
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PPUB - Publication issued
Completion Date
01-Sep-2020
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IEC 60601-1-2:2014/AMD1:2020 - Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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IEC 60601-1-2
Edition 4.0 2020-09
INTERNATIONAL
STANDARD
colour
inside
AMENDMENT 1
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
IEC 60601-1-2:2014-02/AMD1:2020-09(en)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 60601-1-2
Edition 4.0 2020-09
INTERNATIONAL
STANDARD
colour
inside
AMENDMENT 1
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01; 33.100.10; 33.100.20 ISBN 978-2-8322-8630-2

Warning! Make sure that you obtained this publication from an authorized distributor.

® Registered trademark of the International Electrotechnical Commission
---------------------- Page: 3 ----------------------
– 2 – IEC 60601-1-2:2014/AMD1:2020
© IEC 2020
FOREWORD

This amendment has been prepared by subcommittee 62A: Common aspects of electrical

equipment used in medical practice, of IEC technical committee 62: Electrical equipment in

medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/1390/FDIS 62A/1405/RVD

Full information on the voting for the approval of this amendment can be found in the report on

voting indicated in the above table.

The committee has decided that the contents of this amendment and the base publication will

remain unchanged until the stability date indicated on the IEC web site under

"http://webstore.iec.ch" in the data related to the specific publication. At this date, the

publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing

organizations may need a transitional period following publication of a new, amended or revised IEC or

ISO publication in which to make products in accordance with the new requirements and to equip themselves for

conducting new or revised tests. It is the recommendation of the committee that the content of this publication be

adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct understanding

of its contents. Users should therefore print this document using a colour printer.

_____________
---------------------- Page: 4 ----------------------
IEC 60601-1-2:2014/AMD1:2020 – 3 –
© IEC 2020
INTRODUCTION TO AMENDMENT 1

The fourth edition of IEC 60601-1-2 was published in 2014. Since the publication of

IEC 60601-1-2:2014, the IEC Subcommittee (SC) 62A Secretariat has been collecting issues

from a variety of sources including comments from National Committees. At the November 2015

meeting of IEC/SC 62A in Kobe, Japan, the subcommittee initiated a process to identify high-

priority issues that need to be considered in an amendment and should not wait until the fifth

edition of IEC 60601-1-2, which is presently targeted for publication sometime after 2024.

Those issues selected for inclusion on the final "short list" to be addressed in Amendment 1

were those approved by a 2/3 majority of the National Committees present and voting at the

Frankfurt meeting of SC 62A. At the meeting held on 10 October 2016, 15 items were presented

to the National Committees present. All 15 items received the required 2/3 majority of the

National Committees present and voting and have been included in the "short list" for

consideration in preparing Amendment 1. All remaining issues have been placed on a "long list"

for consideration in the fifth edition of IEC 60601-1-2.

The "short list" of issues was documented in the design specification for Amendment 1. MT 23

was directed to consider each issue described in Clause 6 of the design specification and

develop an appropriate solution for the identified problem. That final solution in this amendment

can encompass any technical solution proposed by the author of the issue or it can involve a

different solution developed by the expert group. The expert group can also have recommended

that no change to the standard was justified by the problem statement.

Because this is an amendment to IEC 60601-1-2:2014, the style in force at the time of

publication of IEC 60601-1-2 has been applied to this amendment. The style specified in

ISO/IEC Directives Part 2:2018 has only been applied when implementing the new style

guidance would not result in additional editorial changes.

Users of this document should note that when constructing the dated references to specific

elements in a standard, such as definitions, amendments are only referenced if they modified

the text being cited. For example, if a reference is made to a definition that has not been

modified by an amendment, then the reference to the amendment is not included in the dated

reference.
---------------------- Page: 5 ----------------------
– 4 – IEC 60601-1-2:2014/AMD1:2020
© IEC 2020
1.3.1 IEC 60601-1

Replace, in the second existing paragraph, the first two existing dashes with the following new

dashes:
– "the general standard" designates IEC 60601-1 alone, including any amendments;

– "this collateral standard" designates IEC 60601-1-2 alone, including any amendments;

2 Normative references

Replace the existing references to IEC 60601-1 (including footnote 1), IEC 60601-1-8 (including

footnote 2), IEC 60601-1-11, IEC 60601-1-12 (including footnote 3), IEC 61000-4-5,

IEC 61000-4-11, CISPR 11 (including footnote 6), CISPR 14-1, CISPR 16-1-2 (including

footnote 7), CISPR 32 and ISO 14971 with the following new references:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety

and essential performance
Amendment 1:2012
Amendment 2:2020

IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic

safety and essential performance – Collateral Standard: General requirements, tests and

guidance for alarm systems in medical electrical equipment and medical electrical systems

Amendment 1:2012
Amendment 2:2020

IEC 60601-1-11:2015, 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
Amendment 1:2020

IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for basic

safety and essential performance – Collateral Standard: Requirements for medical electrical

equipment and medical electrical systems intended for use in the emergency medical services

environment
Amendment 1:2020
IEC 61000-4-5:2014, Electromagnetic compatibility (EMC) – Part 4-5: Testing and
measurement techniques – Surge immunity test
Amendment 1:2017

IEC 61000-4-11:2004, Electromagnetic compatibility (EMC) – Part 4-11: Testing and measuring

techniques – Voltage dips, short interruptions and voltage variations immunity tests

Amendment 1:2017

CISPR 11:2015, Industrial, scientific and medical equipment – Radio-frequency disturbance

characteristics – Limits and methods of measurement
Amendment 1:2016
Amendment 2:2019

CISPR 14-1:2016, Electromagnetic compatibility – Requirements for household appliances,

electric tools and similar apparatus – Part 1: Emission

CISPR 16-1-2:2014, Specification for radio disturbance and immunity measuring apparatus

and methods – Part 1-2: Radio disturbance and immunity measuring apparatus – Coupling

devices for conducted disturbance measurements
Amendment 1:2017
---------------------- Page: 6 ----------------------
IEC 60601-1-2:2014/AMD1:2020 – 5 –
© IEC 2020
CISPR 32:2015, Electromagnetic compatibility of multimedia equipment – Emission
requirements

ISO 14971:2019, Medical devices - Application of risk management to medical devices

Delete the existing normative reference to ISO 7137.
Add the following normative reference to the existing list:

IEC 61000-4-39:2017, Electromagnetic compatibility (EMC) – Part 4-39: Testing and

measurement techniques – Radiated fields in close proximity – Immunity test
3 Terms and definitions
Replace the existing first paragraph with the following new paragraph:

For the purposes of this document, the terms and definitions given in IEC 60601-1:2005

+A1:2012+A2:2020, IEC 60601-1-8:2006+A1:2012+A2:2020, IEC 60601-1-11:2015+A1:2020,

IEC 60601-1-12:2014+A1:2020, IEC 60601-2-2:2009, IEC 60601-2-3:2012 and the following

definitions apply.
3.20
SPECIAL ENVIRONMENT

Replace, in the definition, the words "Table 2 through Table 9" with "Table 2 through Table 9

and Table 11".
Table 1 – Power input voltages and frequencies during the tests

Replace the existing header and first row of Table 1 (1 of 2) with the following new header and

first row:
Test Power input voltage Power frequency
Conducted DISTURBANCES
c) d) b)
(conducted EMISSIONS)
Minimum and maximum RATED voltage Any one frequency
CISPR 11
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-1-2:2014/AMD1:2020
© IEC 2020
Replace the existing Table 1 (2 of 2) with the following new table:
Table 1 (2 of 2)
Test Power input voltage Power frequency
Either 50 Hz or 60 Hz. During the
test, the frequency of the
Power frequency magnetic field
generated magnetic field and the
IMMUNITY a)
Any one voltage
power frequency of the ME
IEC 61000-4-8
EQUIPMENT or ME SYSTEM shall be
the same.
Voltage dips IMMUNITY
Minimum and maximum RATED
Any one frequency
c) d)
voltage
IEC 61000-4-11
Voltage short interruptions and
voltage variations IMMUNITY
a) b)
Any one voltage Any one frequency
IEC 61000-4-11
Proximity magnetic fields
a) b)
Any one voltage Any one frequency
IEC 61000-4-39

The test may be performed at any one power input voltage within the ME EQUIPMENT or ME SYSTEM RATED

voltage range. If the ME EQUIPMENT or ME SYSTEM is tested at one power input voltage, it is not necessary to

re-test at additional voltages.

The test may be performed at any one power frequency within the ME EQUIPMENT or ME SYSTEM RATED frequency

range. If the ME EQUIPMENT or ME SYSTEM is tested at one power frequency, it is not necessary to re-test at

additional frequencies.

If the difference between the maximum and the minimum RATED input voltage is less than 25 % of the highest

RATED input voltage, then the test may instead be performed at any one RATED voltage.

ME EQUIPMENT and ME SYSTEMS with power input voltage selection by transformer taps shall be tested at only

one tap setting.
7.1.12 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS
Replace the existing title of the subclause with the following new title:
7.1.12 * PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS
Table 2 – EMISSION limits per environment
c), d)

Replace, in the third column of the first row of the existing Table 2, "CISPR 11 " with

"CISPR 11 ".

Replace, in the existing Table 2, table footnote with the following new footnote:

Standards applicable to modes or EM ENVIRONMENTS of transportation for which use is intended shall apply.

Examples of standards that might be applicable include CISPR 25 and ISO 7637-2.
d)
Delete, in the existing Table 2, table footnote .
8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS
8.1 * General

Replace, in the existing first paragraph following Table 3, "Table 4 through Table 9" with

"Table 4 through Table 9 and 8.11" in four places.
---------------------- Page: 8 ----------------------
IEC 60601-1-2:2014/AMD1:2020 – 7 –
© IEC 2020

Replace, in the existing first paragraph following NOTE 3, "Table 4 through Table 9" with

"Table 4 through Table 9 and 8.11".

Replace, in the existing first paragraph following NOTE 4, "Table 4 through Table 9 for the HOME

HEALTHCARE ENVIRONMENT” with "Table 4 through Table 9 for the HOME HEALTHCARE
ENVIRONMENT, and 8.11”.

Replace, in the existing second paragraph following NOTE 4, "Table 4 through Table 9" with

"Table 4 through Table 9 and 8.11”.

Replace, in the existing sixth paragraph following NOTE 4, "Table 1 and Table 4 through

Table 9" with "Table 1”.

Replace, in the existing last paragraph of the subclause, "Table 4 through Table 9" with "Table 4

through Table 9 and 8.11, as applicable".
ERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS
8.6 P
Replace the existing title of the subclause with the following new title:
ERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS
8.6 * P

Replace, in the existing first paragraph following the NOTE, "8.9 and 8.10" with "8.9, 8.10 and

8.11".
8.9 * IMMUNITY TEST LEVELS

Replace, in the existing first paragraph, "Table 4 through Table 9" with "Table 4 through Table 9

and 8.11".
Delete the existing NOTE.

Replace, in the existing second paragraph, "Table 4 through Table 9" with "Table 4 through

Table 9 and 8.11" in two places.
Figure 3 – Examples of environments of INTENDED USE
Replace the existing title of Figure 3 with the following new title:
Figure 3 – Examples of locations within EM ENVIRONMENTS
Table 4 – * ENCLOSURE PORT
Replace, in the existing Table 4, the fourth row with the following new rows:
d)
IEC 61000-4-8 30 A/m
RATED power frequency magnetic fields
50 Hz or 60 Hz
Proximity magnetic fields IEC 61000-4-39 See 8.11.

Replace, in the existing Table 4, table footnote with the following new footnote:

Void.
Delete, in the existing Table 4, table footnote .
---------------------- Page: 9 ----------------------
– 8 – IEC 60601-1-2:2014/AMD1:2020
© IEC 2020
Table 5 – * Input a.c. power PORT

Replace, in the first column of the first row of the existing Table 5 (1 of 2), "Electrical fast transients

a) l) o) l) o)
/ bursts " with "Electrical fast transients / bursts ".
a) b) j) o)

Replace, in the first column of the second row of the existing Table 5 (1 of 2), "Surges Line-

b) j) o)
to-line" with "Surges Line-to-line".
a) b) j) k) o)

Replace, in the first column of the third row of the existing Table 5 (1 of 2), "Surges Line-

b) j) k) o)
to-ground" with "Surges Line-to-ground".

Replace, in the first column of the sixth row of the existing Table 5 (1 of 2), "Voltage

f) i) o) r) f) i) o)
interruptions " with "Voltage interruptions ".

Replace, in the existing Table 5 (1 of 2), table footnote with the following new footnote:

Void.

Replace, in the existing Table 5 (2 of 2), table footnote with the following new footnote:

For ME EQUIPMENT and ME SYSTEMS that have multiple voltage settings or auto ranging voltage capability, the

test shall be performed at the power input voltage specified in Table 1.
Table 8 – Signal input/output parts PORT
Replace the existing title of Table 8 with the following new title:
Table 8 – SIP/SOP PORT

Replace, in the first column of the fourth row of the existing Table 8, "Conducted disturbances induced

b) d) g) d) g) j) k)
by RF fields " with "Conducted disturbances induced by RF fields ".
Add, in the existing Table 8, the following table footnotes:

See IEC 61000-4-6:2013, Annex B, for modified start frequency versus cable length and equipment size.

SIP/SOPS whose maximum cable length is less than 1 m are excluded.

Table 9 – Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications

equipment
Replace the existing Table 9 with the following new table:
---------------------- Page: 10 ----------------------
IEC 60601-1-2:2014/AMD1:2020 – 9 –
© IEC 2020
Table 9 – Test specifications for ENCLOSURE PORT IMMUNITY to
RF wireless communications equipment
Test IMMUNITY TEST
a) a)
Modulation
Band Service
frequency LEVEL
(MHz) (MHz) (V/m)
b)
Pulse modulation
385 380 to 390 TETRA 400 27
18 Hz
± 5 kHz deviation
450 430 to 470 GMRS 460, FRS 460 28
1 kHz sine
710
Pulse modulation
745 704 to 787 LTE Band 13, 17 9
217 Hz
780
810
GSM 800/900, TETRA 800,
Pulse modulation
870 800 to 960 iDEN 820, CDMA 850, 28
18 Hz
LTE Band 5
930
1 720
GSM 1800; CDMA 1900;
Pulse modulation
1 845 1 700 to 1 990 GSM 1900; DECT; LTE Band
217 Hz
1, 3, 4, 25; UMTS
1 970
Bluetooth, WLAN,
Pulse modulation
2 450 2 400 to 2 570 802.11 b/g/n, RFID 2450, 28
217 Hz
LTE Band 7
5 240
Pulse modulation
5 500 5 100 to 5 800 WLAN 802.11 a/n 9
217 Hz
5 785

If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the

ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

For some services, only the uplink frequencies are included.
The carrier shall be modulated using a 50 % duty cycle square wave signal.

As an alternative to FM modulation, the carrier may be pulse modulated using a 50 % duty cycle square wave

signal at 18 Hz. While it does not represent actual modulation, it would be worst case.

Add, after the existing Subclause 8.10, the following new subclause:

8.11 * IMMUNITY to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz

IMMUNITY to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz shall be

evaluated according to steps a) through d) below. MANUFACTURERS may proceed directly to

step d). The result of the evaluation for each applicable step shall be documented in the test

report or RISK MANAGEMENT FILE, as applicable. See also Figure A.3.

While communication might not be possible when ME EQUIPMENT that includes radio equipment

is tested in its passband, the ME EQUIPMENT or ME SYSTEM shall still be able to provide its BASIC

SAFETY and ESSENTIAL PERFORMANCE.

a) ME EQUIPMENT and ME SYSTEMS that do not contain magnetically sensitive components or

circuitry within the ENCLOSURE or as part of an attached ACCESSORY need not be evaluated

further for IMMUNITY to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz;

otherwise,
---------------------- Page: 11 ----------------------
– 10 – IEC 60601-1-2:2014/AMD1:2020
© IEC 2020

b) ME EQUIPMENT and ME SYSTEMS containing magnetically sensitive components or circuitry

where a separation distance of those components or circuitry of at least 0,15 m from the

field sources specified in Table 11 is ensured by the ENCLOSURE or by the physical design

of an attached ACCESSORY during INTENDED USE need not be evaluated further for IMMUNITY

to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz; otherwise,

c) Perform a RISK ANALYSIS regarding exposure of the ME EQUIPMENT or ME SYSTEM to the

frequencies, field strengths, and modulations specified in Table 11 at separation distances

less than 0,15 m. If the RISK of exposure (during INTENDED USE) to the frequencies, field

strengths, and modulations specified in Table 11 is acceptable, then the tests of Table 11

need not be performed; otherwise,

d) ME EQUIPMENT and ME SYSTEMS containing magnetically sensitive components or circuitry

not meeting the separation distance criteria in b) or the RISK acceptability criteria in c) shall

be tested for IMMUNITY to magnetic fields as specified in Table 11 using the test methods

specified in IEC 61000-4-39. The magnetic field shall be applied only to those surfaces of

the ENCLOSURE or attached ACCESSORIES that are accessible during INTENDED USE. The test

windows to be used with IEC 61000-4-39 may be selected to illuminate only the area of the

magnetically sensitive components or circuitry. The location of application of the magnetic

field should be specified in the test plan and shall be documented in the test report.

Table 11 – Test specifications for ENCLOSURE PORT IMMUNITY to
proximity magnetic fields
Test frequency Modulation IMMUNITY TEST LEVEL (A/m)
a)
30 kHz CW 8
Pulse modulation
c)
134,2 kHz
2,1 kHz
b)
Pulse modulation
c)
13,56 MHz
7,5
50 kHz

This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the HOME HEALTHCARE

ENVIRONMENT.
The carrier shall be modulated using a 50 % duty cycle square wave signal.
r.m.s., before modulation is applied.
9 * Test report
Add, in the existing Table 10 (2 of 2), before the last row:

The locations of application of proximity magnetic If the testing according to 8.11 step d) is

fields. performed.
A.1 Safety and performance

Replace, in the existing NOTE, the reference "IEC/TS 61000-1-2 in the 2008 edition [8]" with

"IEC/TS 61000-1-2:2008".
A.3 Rationale for particular clauses and subclauses
Subclause 4.2 – Non-ME EQUIPMENT used in an ME SYSTEM
Add, immediately following the existing third paragraph, the following new text:
---------------------- Page: 12 ----------------------
IEC 60601-1-2:2014/AMD1:2020 – 11 –
© IEC 2020
For example:
EMISSIONS:

If non-ME EQUIPMENT is used in an ME SYSTEM, the non-ME EQUIPMENT should fulfil the same

EMISSIONS requirements as the ME SYSTEM, proven by the applicable product standards of the

non-ME EQUIPMENT.
MMUNITY:

Consider if failure or degradation of the non-ME EQUIPMENT could result in the loss of BASIC

SAFETY or ESSENTIAL PERFORMANCE of the ME SYSTEM.

– If failure or degradation of the non-ME EQUIPMENT could result in the loss of BASIC SAFETY or

ESSENTIAL PERFORMANCE of the ME SYSTEM, apply to the non-ME EQUIPMENT the same

IMMUNITY TEST LEVELS specified for the ME SYSTEM, based on the environments of INTENDED

USE.

– If failure or degradation of the non-ME EQUIPMENT does not result in the loss of BASIC SAFETY

or ESSENTIAL PERFORMANCE of the ME SYSTEM, compliance with the product standard of the

non-ME EQUIPMENT is sufficient.
Subclause 4.3.3 – Power input voltages and frequencies
Add, immediately following the existing last paragraph, the following new text:

Table 1, table footnote , provides the MANUFACTURER with an allowance to perform testing at

any one RATED input voltage when the difference between the maximum and minimum RATED

input voltage is less than 25 % of the highest RATED input voltage. Table A.2 provides several

examples of the calculation and associated conclusion for testing at a single RATED input

voltage.
Table A.2 – Example calculations for applying the allowance
to test at a single RATED power input voltage
Min. Max. Max. – Min. 25 % of Max. (Max. – Min.) < Testing at one
25 % of Max.? voltage
V V V V allowed?
100 120 20 30 Yes Yes
100 127 27 31,75 Yes Yes
100 240 140 60 No No
200 240 40 60 Yes Yes
380 480 100 120 Yes Yes
Subclause 5.2.2.1 a) – Compliance for each EMISSIONS and IMMUNITY standard

Replace, in the existing paragraph, "Table 4 through Table 9" with "Table 4 through Table 9

and 8.11" in two places.
Subclause 7.1.7 – ME EQUIPMENT whose main functions are performed by motors and
switching or regulating devices

Add, immediately following the existing last paragraph, the following new rationale:

---------------------- Page: 13 ----------------------
– 12 – IEC 60601-1-2:2014/AMD1:2020
© IEC 2020
Subclause 7.1.12 – PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS

This subclause offers three methods for EMISSION testing of PERMANENTLY INSTALLED LARGE

ME EQUIPMENT and LARGE ME SYSTEMS:
– on a test site as a system;
– on a test site on a subsystem basis;
– in situ as a system at the premises of a RESPONSIBLE ORGANIZATION.

For some ME SYSTEMS, testing on a test site or on a subsystem basis is deemed to be very

difficult. ME SYSTEMS (e.g. large X-ray equipment and particle therapy systems) requiring ceiling

installation, or equipment that needs to be placed in different locations such as examination

rooms, technical rooms and control rooms, cannot be installed in today’s test sites due to the

size or installation requirements. Note that "large" in this context is defined in this collateral

ME EQUIPMENT or ME SYSTEMS that cannot fit within a 2 m x 2 m x 2,5 m
standard to mean
volume in any orientation (see 3.12 and 3.13).

Testing on a subsystem basis requires the simulation of physical behaviour of the replaced

system, which is also deemed to be technically very difficult and sometimes impossible without

a representative configuration. Such a test would likely not fulfil the "worst case" or "modes that

maximize EMISSIONS" approach of CISPR 11/IEC 60601-1-2 without several re-configurations

and extensive test time.

In situ testing – testing at the place of installation – as a system, at a RESPONSIBLE ORGANIZATION

(i.e. a hospital or individual clinic) often requires a certification/approval before shipment to the

facility. The ME SYSTEM might be in use and might not present the maximum configuration.

Furthermore, it might not be possible to be tested in the modes that maximize EMISSIONS as

required by this subclause because the available configuration for such testing is limited to what

RESPONSIBLE ORGANIZATION has installed.
the customer/

Moreover, BASIC SAFETY and ESSENTIAL PERFORMANCE needs to be verified according to the

MANUFACTURER's specification and requires specific operating modes and auxiliary equipment

that might not be available or authorized in situ.

At the MANUFACTURER's premises, the equipment used to provide input to, and monitoring of,

the equipment under test (EUT) is likely to be fully available and testing in representative

MANUFACTURER's premises could fulfil the
configurations is usually possible. Testing at the
operational mode requirements of this subclause.

Furthermore, at the MANUFACTURER's premises, all necessary components, service support and

knowledge of maintenance is in place, as well as protection requirements (e.g. to protect the

environment and personnel).

Comparing the limitations as described in this subclause against the advantages of testing at

the MANUFACTURER's premises, the latter could be considered equal to in situ testing. In such

cases, good EMC practice regarding the measurement distance and positions should be

achievable, and for EMISSION testing at the MANUFACTURER's premises, a measurement distance

of at least 3 m should be maintained. Additionally, a rationale to explain why testing the

ME EQUIPMENT or ME SYSTEM on the MANUFACTURER's premises is justified should be provided in

the test plan and documented in the test report. The measurement locations, including distance

to the EUT, should be documented in the test report.
Subclause 8.5 – Subsystems
Add, immediately following the existing paragraph, the following new rationale:
---------------------- Page: 14 ----------------------
IEC 60601-1-2:2014/AMD1:2020 – 13 –
© IEC 2020
Subclause 8.6 – PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS

This subclause offers three methods for IMMUNITY testing of PERMANENTLY INSTALLED LARGE

ME EQUIPMENT and LARGE ME SYSTEMS:
– on a test site as a system;
– on a test site on a subsystem basis;
– in situ as a system at the premises of a RESPONSIBLE ORGANIZATION.

For certain ME SYSTEMS, testing on a test site or on a subsystem basis is deemed to

...

IEC 60601-1-2
Edition 4.0 2020-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
Appareils électromédicaux –
Partie 1-2: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Perturbations électromagnétiques – Exigences
et essais
IEC 60601-1-2:2014-02/AMD1:2020-09(en-fr)
---------------------- Page: 1 ----------------------
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---------------------- Page: 2 ----------------------
IEC 60601-1-2
Edition 4.0 2020-09
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –
Part 1-2: General requirements for basic safety and essential performance –
Collateral Standard: Electromagnetic disturbances – Requirements and tests
Appareils électromédicaux –
Partie 1-2: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Perturbations électromagnétiques – Exigences
et essais
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01; 33.100.10; 33.100.20 ISBN 978-2-8322-1016-2

Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale
---------------------- Page: 3 ----------------------
– 2 – IEC 60601-1-2:2014/AMD1:2020
© IEC 2020
FOREWORD

This amendment has been prepared by subcommittee 62A: Common aspects of electrical

equipment used in medical practice, of IEC technical committee 62: Electrical equipment in

medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/1390/FDIS 62A/1405/RVD

Full information on the voting for the approval of this amendment can be found in the report on

voting indicated in the above table.

The committee has decided that the contents of this amendment and the base publication will

remain unchanged until the stability date indicated on the IEC web site under

"http://webstore.iec.ch" in the data related to the specific publication. At this date, the

publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.

NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing

organizations may need a transitional period following publication of a new, amended or revised IEC or

ISO publication in which to make products in accordance with the new requirements and to equip themselves for

conducting new or revised tests. It is the recommendation of the committee that the content of this publication be

adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct understanding

of its contents. Users should therefore print this document using a colour printer.

_____________
---------------------- Page: 4 ----------------------
IEC 60601-1-2:2014/AMD1:2020 – 3 –
© IEC 2020
INTRODUCTION TO AMENDMENT 1

The fourth edition of IEC 60601-1-2 was published in 2014. Since the publication of

IEC 60601-1-2:2014, the IEC Subcommittee (SC) 62A Secretariat has been collecting issues

from a variety of sources including comments from National Committees. At the November 2015

meeting of IEC/SC 62A in Kobe, Japan, the subcommittee initiated a process to identify high-

priority issues that need to be considered in an amendment and should not wait until the fifth

edition of IEC 60601-1-2, which is presently targeted for publication sometime after 2024.

Those issues selected for inclusion on the final "short list" to be addressed in Amendment 1

were those approved by a 2/3 majority of the National Committees present and voting at the

Frankfurt meeting of SC 62A. At the meeting held on 10 October 2016, 15 items were presented

to the National Committees present. All 15 items received the required 2/3 majority of the

National Committees present and voting and have been included in the "short list" for

consideration in preparing Amendment 1. All remaining issues have been placed on a "long list"

for consideration in the fifth edition of IEC 60601-1-2.

The "short list" of issues was documented in the design specification for Amendment 1. MT 23

was directed to consider each issue described in Clause 6 of the design specification and

develop an appropriate solution for the identified problem. That final solution in this amendment

can encompass any technical solution proposed by the author of the issue or it can involve a

different solution developed by the expert group. The expert group can also have recommended

that no change to the standard was justified by the problem statement.

Because this is an amendment to IEC 60601-1-2:2014, the style in force at the time of

publication of IEC 60601-1-2 has been applied to this amendment. The style specified in

ISO/IEC Directives Part 2:2018 has only been applied when implementing the new style

guidance would not result in additional editorial changes.

Users of this document should note that when constructing the dated references to specific

elements in a standard, such as definitions, amendments are only referenced if they modified

the text being cited. For example, if a reference is made to a definition that has not been

modified by an amendment, then the reference to the amendment is not included in the dated

reference.
---------------------- Page: 5 ----------------------
– 4 – IEC 60601-1-2:2014/AMD1:2020
© IEC 2020
1.3.1 IEC 60601-1

Replace, in the second existing paragraph, the first two existing dashes with the following new

dashes:
– "the general standard" designates IEC 60601-1 alone, including any amendments;

– "this collateral standard" designates IEC 60601-1-2 alone, including any amendments;

2 Normative references

Replace the existing references to IEC 60601-1 (including footnote 1), IEC 60601-1-8 (including

footnote 2), IEC 60601-1-11, IEC 60601-1-12 (including footnote 3), IEC 61000-4-5,

IEC 61000-4-11, CISPR 11 (including footnote 6), CISPR 14-1, CISPR 16-1-2 (including

footnote 7), CISPR 32 and ISO 14971 with the following new references:

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety

and essential performance
Amendment 1:2012
Amendment 2:2020

IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic

safety and essential performance – Collateral Standard: General requirements, tests and

guidance for alarm systems in medical electrical equipment and medical electrical systems

Amendment 1:2012
Amendment 2:2020

IEC 60601-1-11:2015, 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
Amendment 1:2020

IEC 60601-1-12:2014, Medical electrical equipment – Part 1-12: General requirements for basic

safety and essential performance – Collateral Standard: Requirements for medical electrical

equipment and medical electrical systems intended for use in the emergency medical services

environment
Amendment 1:2020
IEC 61000-4-5:2014, Electromagnetic compatibility (EMC) – Part 4-5: Testing and
measurement techniques – Surge immunity test
Amendment 1:2017

IEC 61000-4-11:2004, Electromagnetic compatibility (EMC) – Part 4-11: Testing and measuring

techniques – Voltage dips, short interruptions and voltage variations immunity tests

Amendment 1:2017

CISPR 11:2015, Industrial, scientific and medical equipment – Radio-frequency disturbance

characteristics – Limits and methods of measurement
Amendment 1:2016
Amendment 2:2019

CISPR 14-1:2016, Electromagnetic compatibility – Requirements for household appliances,

electric tools and similar apparatus – Part 1: Emission

CISPR 16-1-2:2014, Specification for radio disturbance and immunity measuring apparatus

and methods – Part 1-2: Radio disturbance and immunity measuring apparatus – Coupling

devices for conducted disturbance measurements
Amendment 1:2017
---------------------- Page: 6 ----------------------
IEC 60601-1-2:2014/AMD1:2020 – 5 –
© IEC 2020
CISPR 32:2015, Electromagnetic compatibility of multimedia equipment – Emission
requirements

ISO 14971:2019, Medical devices - Application of risk management to medical devices

Delete the existing normative reference to ISO 7137.
Add the following normative reference to the existing list:

IEC 61000-4-39:2017, Electromagnetic compatibility (EMC) – Part 4-39: Testing and

measurement techniques – Radiated fields in close proximity – Immunity test
3 Terms and definitions
Replace the existing first paragraph with the following new paragraph:

For the purposes of this document, the terms and definitions given in IEC 60601-1:2005

+A1:2012+A2:2020, IEC 60601-1-8:2006+A1:2012+A2:2020, IEC 60601-1-11:2015+A1:2020,

IEC 60601-1-12:2014+A1:2020, IEC 60601-2-2:2009, IEC 60601-2-3:2012 and the following

definitions apply.
3.20
SPECIAL ENVIRONMENT

Replace, in the definition, the words "Table 2 through Table 9" with "Table 2 through Table 9

and Table 11".
Table 1 – Power input voltages and frequencies during the tests

Replace the existing header and first row of Table 1 (1 of 2) with the following new header and

first row:
Test Power input voltage Power frequency
Conducted DISTURBANCES
c) d) b)
(conducted EMISSIONS)
Minimum and maximum RATED voltage Any one frequency
CISPR 11
---------------------- Page: 7 ----------------------
– 6 – IEC 60601-1-2:2014/AMD1:2020
© IEC 2020
Replace the existing Table 1 (2 of 2) with the following new table:
Table 1 (2 of 2)
Test Power input voltage Power frequency
Either 50 Hz or 60 Hz. During the
test, the frequency of the
Power frequency magnetic field
generated magnetic field and the
IMMUNITY a)
Any one voltage
power frequency of the ME
IEC 61000-4-8
EQUIPMENT or ME SYSTEM shall be
the same.
Voltage dips IMMUNITY
Minimum and maximum RATED
Any one frequency
c) d)
voltage
IEC 61000-4-11
Voltage short interruptions and
voltage variations IMMUNITY
a) b)
Any one voltage Any one frequency
IEC 61000-4-11
Proximity magnetic fields
a) b)
Any one voltage Any one frequency
IEC 61000-4-39

The test may be performed at any one power input voltage within the ME EQUIPMENT or ME SYSTEM RATED

voltage range. If the ME EQUIPMENT or ME SYSTEM is tested at one power input voltage, it is not necessary to

re-test at additional voltages.

The test may be performed at any one power frequency within the ME EQUIPMENT or ME SYSTEM RATED frequency

range. If the ME EQUIPMENT or ME SYSTEM is tested at one power frequency, it is not necessary to re-test at

additional frequencies.

If the difference between the maximum and the minimum RATED input voltage is less than 25 % of the highest

RATED input voltage, then the test may instead be performed at any one RATED voltage.

ME EQUIPMENT and ME SYSTEMS with power input voltage selection by transformer taps shall be tested at only

one tap setting.
7.1.12 PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS
Replace the existing title of the subclause with the following new title:
7.1.12 * PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS
Table 2 – EMISSION limits per environment
c), d)

Replace, in the third column of the first row of the existing Table 2, "CISPR 11 " with

"CISPR 11 ".

Replace, in the existing Table 2, table footnote with the following new footnote:

Standards applicable to modes or EM ENVIRONMENTS of transportation for which use is intended shall apply.

Examples of standards that might be applicable include CISPR 25 and ISO 7637-2.
d)
Delete, in the existing Table 2, table footnote .
8 Electromagnetic IMMUNITY requirements for ME EQUIPMENT and ME SYSTEMS
8.1 * General

Replace, in the existing first paragraph following Table 3, "Table 4 through Table 9" with

"Table 4 through Table 9 and 8.11" in four places.
---------------------- Page: 8 ----------------------
IEC 60601-1-2:2014/AMD1:2020 – 7 –
© IEC 2020

Replace, in the existing first paragraph following NOTE 3, "Table 4 through Table 9" with

"Table 4 through Table 9 and 8.11".

Replace, in the existing first paragraph following NOTE 4, "Table 4 through Table 9 for the HOME

HEALTHCARE ENVIRONMENT” with "Table 4 through Table 9 for the HOME HEALTHCARE
ENVIRONMENT, and 8.11”.

Replace, in the existing second paragraph following NOTE 4, "Table 4 through Table 9" with

"Table 4 through Table 9 and 8.11”.

Replace, in the existing sixth paragraph following NOTE 4, "Table 1 and Table 4 through

Table 9" with "Table 1”.

Replace, in the existing last paragraph of the subclause, "Table 4 through Table 9" with "Table 4

through Table 9 and 8.11, as applicable".
ERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS
8.6 P
Replace the existing title of the subclause with the following new title:
ERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS
8.6 * P

Replace, in the existing first paragraph following the NOTE, "8.9 and 8.10" with "8.9, 8.10 and

8.11".
8.9 * IMMUNITY TEST LEVELS

Replace, in the existing first paragraph, "Table 4 through Table 9" with "Table 4 through Table 9

and 8.11".
Delete the existing NOTE.

Replace, in the existing second paragraph, "Table 4 through Table 9" with "Table 4 through

Table 9 and 8.11" in two places.
Figure 3 – Examples of environments of INTENDED USE
Replace the existing title of Figure 3 with the following new title:
Figure 3 – Examples of locations within EM ENVIRONMENTS
Table 4 – * ENCLOSURE PORT
Replace, in the existing Table 4, the fourth row with the following new rows:
d)
IEC 61000-4-8 30 A/m
RATED power frequency magnetic fields
50 Hz or 60 Hz
Proximity magnetic fields IEC 61000-4-39 See 8.11.

Replace, in the existing Table 4, table footnote with the following new footnote:

Void.
Delete, in the existing Table 4, table footnote .
---------------------- Page: 9 ----------------------
– 8 – IEC 60601-1-2:2014/AMD1:2020
© IEC 2020
Table 5 – * Input a.c. power PORT

Replace, in the first column of the first row of the existing Table 5 (1 of 2), "Electrical fast transients

a) l) o) l) o)
/ bursts " with "Electrical fast transients / bursts ".
a) b) j) o)

Replace, in the first column of the second row of the existing Table 5 (1 of 2), "Surges Line-

b) j) o)
to-line" with "Surges Line-to-line".
a) b) j) k) o)

Replace, in the first column of the third row of the existing Table 5 (1 of 2), "Surges Line-

b) j) k) o)
to-ground" with "Surges Line-to-ground".

Replace, in the first column of the sixth row of the existing Table 5 (1 of 2), "Voltage

f) i) o) r) f) i) o)
interruptions " with "Voltage interruptions ".

Replace, in the existing Table 5 (1 of 2), table footnote with the following new footnote:

Void.

Replace, in the existing Table 5 (2 of 2), table footnote with the following new footnote:

For ME EQUIPMENT and ME SYSTEMS that have multiple voltage settings or auto ranging voltage capability, the

test shall be performed at the power input voltage specified in Table 1.
Table 8 – Signal input/output parts PORT
Replace the existing title of Table 8 with the following new title:
Table 8 – SIP/SOP PORT

Replace, in the first column of the fourth row of the existing Table 8, "Conducted disturbances induced

b) d) g) d) g) j) k)
by RF fields " with "Conducted disturbances induced by RF fields ".
Add, in the existing Table 8, the following table footnotes:

See IEC 61000-4-6:2013, Annex B, for modified start frequency versus cable length and equipment size.

SIP/SOPS whose maximum cable length is less than 1 m are excluded.

Table 9 – Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications

equipment
Replace the existing Table 9 with the following new table:
---------------------- Page: 10 ----------------------
IEC 60601-1-2:2014/AMD1:2020 – 9 –
© IEC 2020
Table 9 – Test specifications for ENCLOSURE PORT IMMUNITY to
RF wireless communications equipment
Test IMMUNITY TEST
a) a)
Modulation
Band Service
frequency LEVEL
(MHz) (MHz) (V/m)
b)
Pulse modulation
385 380 to 390 TETRA 400 27
18 Hz
± 5 kHz deviation
450 430 to 470 GMRS 460, FRS 460 28
1 kHz sine
710
Pulse modulation
745 704 to 787 LTE Band 13, 17 9
217 Hz
780
810
GSM 800/900, TETRA 800,
Pulse modulation
870 800 to 960 iDEN 820, CDMA 850, 28
18 Hz
LTE Band 5
930
1 720
GSM 1800; CDMA 1900;
Pulse modulation
1 845 1 700 to 1 990 GSM 1900; DECT; LTE Band
217 Hz
1, 3, 4, 25; UMTS
1 970
Bluetooth, WLAN,
Pulse modulation
2 450 2 400 to 2 570 802.11 b/g/n, RFID 2450, 28
217 Hz
LTE Band 7
5 240
Pulse modulation
5 500 5 100 to 5 800 WLAN 802.11 a/n 9
217 Hz
5 785

If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the

ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

For some services, only the uplink frequencies are included.
The carrier shall be modulated using a 50 % duty cycle square wave signal.

As an alternative to FM modulation, the carrier may be pulse modulated using a 50 % duty cycle square wave

signal at 18 Hz. While it does not represent actual modulation, it would be worst case.

Add, after the existing Subclause 8.10, the following new subclause:

8.11 * IMMUNITY to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz

IMMUNITY to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz shall be

evaluated according to steps a) through d) below. MANUFACTURERS may proceed directly to

step d). The result of the evaluation for each applicable step shall be documented in the test

report or RISK MANAGEMENT FILE, as applicable. See also Figure A.3.

While communication might not be possible when ME EQUIPMENT that includes radio equipment

is tested in its passband, the ME EQUIPMENT or ME SYSTEM shall still be able to provide its BASIC

SAFETY and ESSENTIAL PERFORMANCE.

a) ME EQUIPMENT and ME SYSTEMS that do not contain magnetically sensitive components or

circuitry within the ENCLOSURE or as part of an attached ACCESSORY need not be evaluated

further for IMMUNITY to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz;

otherwise,
---------------------- Page: 11 ----------------------
– 10 – IEC 60601-1-2:2014/AMD1:2020
© IEC 2020

b) ME EQUIPMENT and ME SYSTEMS containing magnetically sensitive components or circuitry

where a separation distance of those components or circuitry of at least 0,15 m from the

field sources specified in Table 11 is ensured by the ENCLOSURE or by the physical design

of an attached ACCESSORY during INTENDED USE need not be evaluated further for IMMUNITY

to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz; otherwise,

c) Perform a RISK ANALYSIS regarding exposure of the ME EQUIPMENT or ME SYSTEM to the

frequencies, field strengths, and modulations specified in Table 11 at separation distances

less than 0,15 m. If the RISK of exposure (during INTENDED USE) to the frequencies, field

strengths, and modulations specified in Table 11 is acceptable, then the tests of Table 11

need not be performed; otherwise,

d) ME EQUIPMENT and ME SYSTEMS containing magnetically sensitive components or circuitry

not meeting the separation distance criteria in b) or the RISK acceptability criteria in c) shall

be tested for IMMUNITY to magnetic fields as specified in Table 11 using the test methods

specified in IEC 61000-4-39. The magnetic field shall be applied only to those surfaces of

the ENCLOSURE or attached ACCESSORIES that are accessible during INTENDED USE. The test

windows to be used with IEC 61000-4-39 may be selected to illuminate only the area of the

magnetically sensitive components or circuitry. The location of application of the magnetic

field should be specified in the test plan and shall be documented in the test report.

Table 11 – Test specifications for ENCLOSURE PORT IMMUNITY to
proximity magnetic fields
Test frequency Modulation IMMUNITY TEST LEVEL (A/m)
a)
30 kHz CW 8
Pulse modulation
c)
134,2 kHz
2,1 kHz
b)
Pulse modulation
c)
13,56 MHz
7,5
50 kHz

This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the HOME HEALTHCARE

ENVIRONMENT.
The carrier shall be modulated using a 50 % duty cycle square wave signal.
r.m.s., before modulation is applied.
9 * Test report
Add, in the existing Table 10 (2 of 2), before the last row:

The locations of application of proximity magnetic If the testing according to 8.11 step d) is

fields. performed.
A.1 Safety and performance

Replace, in the existing NOTE, the reference "IEC/TS 61000-1-2 in the 2008 edition [8]" with

"IEC/TS 61000-1-2:2008".
A.3 Rationale for particular clauses and subclauses
Subclause 4.2 – Non-ME EQUIPMENT used in an ME SYSTEM
Add, immediately following the existing third paragraph, the following new text:
---------------------- Page: 12 ----------------------
IEC 60601-1-2:2014/AMD1:2020 – 11 –
© IEC 2020
For example:
EMISSIONS:

If non-ME EQUIPMENT is used in an ME SYSTEM, the non-ME EQUIPMENT should fulfil the same

EMISSIONS requirements as the ME SYSTEM, proven by the applicable product standards of the

non-ME EQUIPMENT.
MMUNITY:

Consider if failure or degradation of the non-ME EQUIPMENT could result in the loss of BASIC

SAFETY or ESSENTIAL PERFORMANCE of the ME SYSTEM.

– If failure or degradation of the non-ME EQUIPMENT could result in the loss of BASIC SAFETY or

ESSENTIAL PERFORMANCE of the ME SYSTEM, apply to the non-ME EQUIPMENT the same

IMMUNITY TEST LEVELS specified for the ME SYSTEM, based on the environments of INTENDED

USE.

– If failure or degradation of the non-ME EQUIPMENT does not result in the loss of BASIC SAFETY

or ESSENTIAL PERFORMANCE of the ME SYSTEM, compliance with the product standard of the

non-ME EQUIPMENT is sufficient.
Subclause 4.3.3 – Power input voltages and frequencies
Add, immediately following the existing last paragraph, the following new text:

Table 1, table footnote , provides the MANUFACTURER with an allowance to perform testing at

any one RATED input voltage when the difference between the maximum and minimum RATED

input voltage is less than 25 % of the highest RATED input voltage. Table A.2 provides several

examples of the calculation and associated conclusion for testing at a single RATED input

voltage.
Table A.2 – Example calculations for applying the allowance
to test at a single RATED power input voltage
Min. Max. Max. – Min. 25 % of Max. (Max. – Min.) < Testing at one
25 % of Max.? voltage
V V V V allowed?
100 120 20 30 Yes Yes
100 127 27 31,75 Yes Yes
100 240 140 60 No No
200 240 40 60 Yes Yes
380 480 100 120 Yes Yes
Subclause 5.2.2.1 a) – Compliance for each EMISSIONS and IMMUNITY standard

Replace, in the existing paragraph, "Table 4 through Table 9" with "Table 4 through Table 9

and 8.11" in two places.
Subclause 7.1.7 – ME EQUIPMENT whose main functions are performed by motors and
switching or regulating devices

Add, immediately following the existing last paragraph, the following new rationale:

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– 12 – IEC 60601-1-2:2014/AMD1:2020
© IEC 2020
Subclause 7.1.12 – PERMANENTLY INSTALLED LARGE ME EQUIPMENT and LARGE ME SYSTEMS

This subclause offers three methods for EMISSION testing of PERMANENTLY INSTALLED LARGE

ME EQUIPMENT and LARGE ME SYSTEMS:
– on a test site as a system;
– on a test site on a subsystem basis;
– in situ as a system at the premises of a RESPONSIBLE ORGANIZATION.

For some ME SYSTEMS, testing on a test site or on a subsystem basis is deemed to be very

difficult. ME SYSTEMS (e.g. large X-ray equipment and particle therapy systems) requiring ceiling

installation, or equipment that needs to be placed in different locations such as examination

rooms, technical rooms and control rooms, cannot be installed in today’s test sites due to the

size or installation requirements. Note that "large" in this context is defined in this collateral

ME EQUIPMENT or ME SYSTEMS that cannot fit within a 2 m x 2 m x 2,5 m
standard to mean
volume in any orientation (see 3.12 and 3.13).
...

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