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

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

General Information

• Status: Published
• Publication Date: 31-Aug-2020
• ICS: 11.040.01 - Medical equipment in general
• ICS: 33.100.10 - Emission
• ICS: 33.100.20 - Immunity
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Current Stage: PPUB - Publication issued
• Start Date: 07-Aug-2020
• Completion Date: 01-Sep-2020

Relations

• Amends: IEC 60601-1-2:2014 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• Effective Date: 05-Sep-2023

Standards Content (Sample)

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)

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
IEC Central Office Tel.: [phone]
3, rue de Varembé [e-mail]
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary
(IEV) online.
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need further assistance, please contact the Customer Service
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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
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01; 33.100.10; 33.100.20 ISBN 978-2-8322-8630-2
– 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.

_____________
© 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.
– 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
© 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
– 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
b)
the same.
Voltage dips IMMUNITY
Minimum and maximum RATED
b)
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
a)
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.
b)
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.
c)
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.
d)
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
c)
"CISPR 11 ".
c)
Replace, in the existing Table 2, table footnote with the following new footnote:
c)
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.

© 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
...

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)

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
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copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform IEC online collection - oc.iec.ch
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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

– 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.

_____________
© 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.
– 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
© 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
– 6
...