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/A1:2020)

2020-11-16_JO_BT167/DG11868/DV to remove the link to (MDD 93/42/EEC) and M/295

Medizinische elektrische Geräte - Teil 1-2: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Elektromagnetische Störgrößen - Anforderungen und Prüfungen (IEC 60601-1-2:2014/A1:2020)

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/A1:2020)

Medicinska električna oprema - 1-2. del: Splošne zahteve za osnovno varnost in bistvene tehnične lastnosti - Spremljevalni standard: Elektromagnetne motnje - Zahteve in preskušanje - Dopolnilo A1 (IEC 60601-1-2:2014/A1:2020)

General Information

Status
Published
Publication Date
22-Apr-2021
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
31-Mar-2021
Due Date
05-Jun-2021
Completion Date
23-Apr-2021

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SLOVENSKI STANDARD
SIST EN 60601-1-2:2015/A1:2021
01-junij-2021
Medicinska električna oprema - 1-2. del: Splošne zahteve za osnovno varnost in
bistvene tehnične lastnosti - Spremljevalni standard: Elektromagnetne motnje -
Zahteve in preskušanje - Dopolnilo A1 (IEC 60601-1-2:2014/A1:2020)

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/A1:2020)

Medizinische elektrische Geräte - Teil 1-2: Allgemeine Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm:
Elektromagnetische Störgrößen - Anforderungen und Prüfungen (IEC 60601-1-
2:2014/A1:2020)

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/A1:2020)
Ta slovenski standard je istoveten z: EN 60601-1-2:2015/A1:2021
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
33.100.01 Elektromagnetna združljivost Electromagnetic compatibility
na splošno in general
SIST EN 60601-1-2:2015/A1:2021 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 60601-1-2:2015/A1:2021
---------------------- Page: 2 ----------------------
SIST EN 60601-1-2:2015/A1:2021
EUROPEAN STANDARD EN 60601-1-2:2015/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2021
ICS 11.040.01; 33.100.10; 33.100.20
English Version
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/A1:2020)

Appareils électromédicaux - Partie 1-2: Exigences Medizinische elektrische Geräte - Teil 1-2: Allgemeine

générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der

essentielles - Norme collatérale: Perturbations wesentlichen Leistungsmerkmale - Ergänzungsnorm:

électromagnétiques - Exigences et essais Elektromagnetische Störgrößen - Anforderungen und

(IEC 60601-1-2:2014/A1:2020) Prüfungen
(IEC 60601-1-2:2014/A1:2020)

This amendment A1 modifies the European Standard EN 60601-1-2:2015; it was approved by CENELEC on 2020-10-06. CENELEC

members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the

status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC

Management Centre or to any CENELEC member.

This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the

responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as

the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,

Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the

Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,

Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.

Ref. No. EN 60601-1-2:2015/A1:2021 E
---------------------- Page: 3 ----------------------
SIST EN 60601-1-2:2015/A1:2021
EN 60601-1-2:2015/A1:2021 (E)
European foreword

The text of document 62A/1390/FDIS, future IEC 60601-1-2/A1, prepared by SC 62A “Common

aspects of electrical equipment used in medical practice” of IEC/TC 62 “Electrical equipment in

medical practice” was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as

EN 60601-1-2:2015/A1:2021.
The following dates are fixed:

• latest date by which the document has to be implemented at national (dop) 2021–09–19

level by publication of an identical national standard or by endorsement

• latest date by which the national standards conflicting with the (dow) 2024–03–19

document have to be withdrawn

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.

Endorsement notice

The text of the International Standard IEC 60601-1-2:2014/A1:2020 was approved by CENELEC as a

European Standard without any modification.

In the official version, for Bibliography, the following notes have to be added for the standards

indicated:
IEC 61000-1-2:2016 NOTE Harmonized as EN 61000-1-2:2016 (not modified)
IEC 60601-2 (series) NOTE Harmonized as EN 60601-2 (series)
ISO/TR 24971:2020 NOTE Harmonized as CEN ISO/TR 24971:2020 (not modified)
CISPR 35:2016 NOTE Harmonized as EN 55035:2017
---------------------- Page: 4 ----------------------
SIST EN 60601-1-2:2015/A1:2021
EN 60601-1-2:2015/A1:2021 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments)

applies.

NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod), the

relevant EN/HD applies.

NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available

here: www.cenelec.eu.

Replace the existing references to IEC 60601-1, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-1-12,

IEC 61000-4-5, IEC 61000-4-11, CISPR 11, CISPR 14-1, CISPR 16-1-2, CISPR 32 and ISO 14971

with the following:
Publication Year Title EN/HD Year

IEC 60601-1 > requirements for basic safety and essential
performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 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
+ A1 2012 + A1 2013
- - + AC 2014
+ A2 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
+ A1 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 used in the
emergency medical services environment
+ A1 2020 + A1 2020
---------------------- Page: 5 ----------------------
SIST EN 60601-1-2:2015/A1:2021
EN 60601-1-2:2015/A1:2021 (E)
Publication Year Title EN/HD Year

IEC 61000-4-5 2014 Electromagnetic compatibility (EMC) - Part 4–5: EN 61000-4-5 2014

Testing and measurement techniques - Surge
immunity test
+ A1 2017 + A1 2017

IEC 61000-4-11 2004 Electromagnetic compatibility (EMC) - Part 4–11: EN 61000-4-11 2004

Testing and measurement techniques - Voltage
dips, short interruptions and voltage variations
immunity tests
+ A1 2017 + A1 2017

IEC 61000-4-39 2017 Electromagnetic compatibility (EMC) – Part 4–39: EN 61000-4-39 2017

Testing and measurement techniques – Radiated
fields in close proximity – Immunity test
CISPR 11 (mod) 2015 Industrial, scientific and medical equipment - EN 55011 2016
Radio-frequency disturbance characteristics -
Limits and methods of measurement
+ A1 2016 + A1 2017
- - + A11 2020
+ A2 2019 - -
CISPR 14-1 2016 Electromagnetic compatibility - Requirements for EN 55014-1 2017
household appliances, electric tools and similar
apparatus - Part 1: Emission
- - + A11 2020
CISPR 32 2015 Electromagnetic compatibility of multimedia EN 55032 2015
equipment - Emission requirements
- - + A11 2020
ISO 14971 2019 Medical devices – Application of risk EN ISO 14971 2019
management to medical devices
Delete the reference to ISO 7137.
Add the following normative reference:
Publication Year Title EN/HD Year
CISPR 16-1-2 2014 Specification for radio disturbance and EN 55016-1-2 2014
immunity measuring apparatus and
methods - Part 1–2: Radio disturbance
and immunity measuring apparatus -
Coupling devices for conducted
disturbance measurements
+ A1 2017 + A1 2018
---------------------- Page: 6 ----------------------
SIST EN 60601-1-2:2015/A1:2021
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: 7 ----------------------
SIST EN 60601-1-2:2015/A1:2021
– 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: 8 ----------------------
SIST EN 60601-1-2:2015/A1:2021
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: 9 ----------------------
SIST EN 60601-1-2:2015/A1:2021
– 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: 10 ----------------------
SIST EN 60601-1-2:2015/A1:2021
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: 11 ----------------------
SIST EN 60601-1-2:2015/A1:2021
– 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: 12 ----------------------
SIST EN 60601-1-2:2015/A1:2021
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: 13 ----------------------
SIST EN 60601-1-2:2015/A1:2021
– 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: 14 ----------------------
SIST EN 60601-1-2:2015/A1:2021
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,
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SIST EN 60601-1-2:2015/A1:2021
– 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 si
...

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