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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 (includin
...