EN 60601-1-2:2015/A1:2021

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

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

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
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
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
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
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 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.
– 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 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
– 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 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.

e)
Replace, in the existing Table 4, table footnote with the following new footnote:
e)
Void.
g)
Delete, in the existing Table 4, table footnote .

– 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 ".
a)
Replace, in the existing Table 5 (1 of 2), table footnote with the following new footnote:
a)
Void.
r)
Replace, in the existing Table 5 (2 of 2), table footnote with the following new footnote:
r)
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:
j)
See IEC 61000-4-6:2013, Annex B, for modified start frequency versus cable length and equipment size.
k)
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:

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
c)
FM
± 5 kHz deviation
450 430 to 470 GMRS 460, FRS 460 28
1 kHz sine
b)
Pulse modulation
745 704 to 787 LTE Band 13, 17 9
217 Hz
b)
GSM 800/900, TETRA 800,
Pulse modulation
870 800 to 960 iDEN 820, CDMA 850, 28
18 Hz
LTE Band 5
1 720
b)
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
b)
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
b)
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.
a)
For some services, only the uplink frequencies are included.
b)
The carrier shall be modulated using a 50 % duty cycle square wave signal.
c)
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,
– 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
b)
Pulse modulation
c)
134,2 kHz
2,1 kHz
b)
Pulse modulation
c)
13,56 MHz
7,5
50 kHz
a)
This test is applicable only to ME EQUIPMENT and ME SYSTEMS intended for use in the HOME HEALTHCARE

ENVIRONMENT.
b)
The carrier shall be modulated using a 50 % duty cycle square wave signal.
c)
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:

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:
I
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:
c)
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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© 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:

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 be very
difficult. ME SYSTEMS (e.g. large X-ray equipment and particle therapy systems) requiring ceiling
installation or of 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
standard to mean ME EQUIPMENT and ME SYSTEMS that cannot fit within a 2 m × 2 m × 2,5 m
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.
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. To operate
the device in the modes and settings that are most likely to result in an unacceptable RISK might
RESPONSIBLE ORGANIZATION due to the potential for damage to the
not be allowed by the
ME SYSTEM.
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 EUT is likely to be fully available and testing in representative configurations is usually
possible. Testing at the MANUFACTURER's premises could fulfil 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 needs to be maintained, and if the
applicable basic EMC standards allow in situ testing, the requirements in the basic EMC
standards will take precedence. 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.
Subclause 8.9 – IMMUNITY TEST LEVELS
b) Environments
Replace, in the existing second paragraph, "Table 4 through Table 9" with "Table 4 through
Table 9 and 8.11".
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© IEC 2020
c) IMMUNITY TEST LEVEL determination
Replace, in the existing second paragraph, "Table 4 through Table 9" with "Table 4 through
Table 9 and 8.11".
– IMMUNITY to proximity fields from RF wireless communications
Subclause 8.10
equipment
Delete the existing fourth and fifth paragraphs.
Replace the existing second-to-last paragraph with the following new paragraph:
The IMMUNITY TEST LEVELS specified in Table 9 were calculated using the maximum power shown
in Table A.3, an assumed separation distance of 0,3 m, and the following equation:
Add, following the existing last paragraph, the following table and text:
Table A.3 – Test specifications for ENCLOSURE PORT IMMUNITY to
RF wireless communications equipment
IMMUNITY TEST
a) a)
Test frequency Maximum power
Band Service
LEVEL
MHz MHz W V/m
385 380 to 390 TETRA 400 1,8 27
450 430 to 470 GMRS 460, FRS 460 2 28
745 704 to 787 LTE Band 13, 17 0,2 9
GSM 800/900,
TETRA 800, iDEN 820,
870 800 to 960 2 28
CDMA 850, LTE Band
GSM 1800;
1 720
CDMA 1900;
1 845
1 700 to 1 990 GSM 1900; DECT; 2 28
LTE Band 1, 3, 4, 25;
1 970
UMTS
Bluetooth, WLAN,
802.11 b/g/n,
2 450 2 400 to 2 570 2 28
RFID 2450,
LTE Band 7
5 240
5 500 5 100 to 5 800 WLAN 802.11 a/n 0,2 9
5 785
a)
For some services, only the uplink frequencies are included.

Subclause 8.11 – IMMUNITY to proximity magnetic fields in the frequency range 9 kHz to
13,56 MHz
This requirement was added due to concerns about the RISKS associated with fields radiated by
a wide variety of sources in both the professional healthcare facility environment and the HOME
HEALTHCARE ENVIRONMENT. ME EQUIPMENT can contain electronic components and circuitry that
are sensitive to radiated magnetic fields from these sources.

IEC 60601-1-2:2014/AMD1:2020 – 15 –
© IEC 2020
The procedure for determining the applicability of the proximity magnetic fields IMMUNITY test
and the testing required are shown in Figure A.3. In general, this subclause applies to all
ME EQUIPMENT and ME SYSTEMS. However, due to the fact that the sources of magnetic fields
considered for this subclause are proximity sources, appropriate exemptions from testing are
specified. Even if this test is not performed, there are requirements for documentation of the
MANUFACTURERS are permitted to bypass these
choices/decisions made. It should be noted that
exemptions and conduct the tests if they so choose.
Exemptions
The first of three exemptions (see 8.11 a)) is where the ME EQUIPMENT or ME SYSTEM does not
contain (i.e. within the ENCLOSURE or as part of an attached ACCESSORY) magnetically sensitive
components or circuitry.
For the purposes of this subclause, magnetically sensitive components are those components
that are either designed to sense magnetic fields or are likely to be influenced as a result of the
fields specified in this subclause while in close proximity to the sources. Examples include but
are not limited to coils, signal transformers, and hall-effect sensors.
Magnetically sensitive circuitry includes but is not limited to those circuits where voltages
induced into wiring or the interconnect structure might alter the intended function of the circuit.
Examples of such circuits are:
– an analogue signal processing circuit whose passband is within the frequency range
specified in this subclause and where the area enclosed by any interconnecting pathways
is such that the induced voltage can interfere with signals of interest.
– digital circuits where the induced voltage in an interconnect pathway approaches the logic
threshold of the devices.
– an external pacemaker system, where the leads attached to temporarily implanted heart
wires form a loop whose area is sufficient to result in an induced voltage comparable to the
ECG signals being sensed from the heart.

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© IEC 2020
Figure A.3 – Steps for evaluation of IMMUNITY to proximity magnetic fields

IEC 60601-1-2:2014/AMD1:2020 – 17 –
© IEC 2020
The second exemption (see 8.11 b)) specified by this subclause is allowed when the
ME EQUIPMENT or ME SYSTEM or an attached ACCESSORY does contain magnetically sensitive
components or circuitry but these components or circuits are mounted behind the surface of the
equipment ENCLOSURE (or the ENCLOSURE or other physical barrier associated with an attached
ACCESSORY) such that during INTENDED USE a minimum separation distance from the sources of
proximity magnetic fields specified in Table 11 is ensured. For the purposes of this collateral
standard, this minimum separation distance is considered to be a “proximity threshold”, and a
value of 0,15 m was assigned to it. To establish t
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