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SLOVENSKI STANDARD
01-september-2021
Medicinska električna oprema - 1-6. del: Splošne zahteve za osnovno varnost in
bistvene tehnične lastnosti - Spremljevalni standard: uporabnost - Dopolnilo A2
(IEC 60601-1-6:2010/A2:2020)
Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability (IEC 60601-1-6:2010/A2:2020)
Medizinische elektrische Geräte - Teil 1-6: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm:
Gebrauchstauglichkeit (IEC 60601-1-6:2010/A2:2020)
Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Aptitude à l'utilisation (IEC 60601-1-
6:2010/A2:2020)
Ta slovenski standard je istoveten z: EN 60601-1-6:2010/A2:2021
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN 60601-1-6:2010/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2021
ICS 11.040.01
English Version
Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard:
Usability
(IEC 60601-1-6:2010/A2:2020)
Appareils électromédicaux - Partie 1-6: Exigences Medizinische elektrische Geräte - Teil 1-6: Allgemeine
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles - Norme collatérale: Aptitude à l'utilisation wesentlichen Leistungsmerkmale - Ergänzungsnorm:
(IEC 60601-1-6:2010/A2:2020) Gebrauchstauglichkeit
(IEC 60601-1-6:2010/A2:2020)
This amendment A2 modifies the European Standard EN 60601-1-6:2010; it was approved by CENELEC on 2020-08-26. 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 60601-1-6:2010/A2:2021 E
European foreword
The text of document 62A/1391/FDIS, future IEC 60601-1-6/A2, 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) 2022-01-16
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-07-16
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.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-1-6:2010/A2:2020 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
ISO 14155 NOTE Harmonized as EN ISO 14155
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 Annex ZA by the following one:
Publication Year Title EN/HD Year
IEC 60601-1 2005 Medical electrical equipment - Part 1: EN 60601-1 2006
General requirements for basic safety and
essential performance
- - + corrigendum Mar. 2010
+ A1 2012 + A1 2013
- - + A12 2014
+ A2 2020 + A2 2021
IEC 62366-1 2015 Medical devices - Part 1: Application of EN 62366-1 2015
usability engineering to medical devices
- - + AC 2015
+ A1 2020 + A1 2020
ISO 14971 2019 Medical devices – Application of risk EN ISO 14971 2019
management to medical devices
IEC 60601-1-6
Edition 3.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 2
AM ENDEMENT 2
Medical electrical equipment –
Part 1-6: General requirements for basic safety and essential performance –
Collateral standard: Usability
Appareils électromédicaux –
Partie 1-6: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Aptitude à l'utilisation
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-8628-9
– 2 – IEC 60601-1-6:2010/AMD2:2020
© 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/1391/FDIS 62A/1406/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.
_____________
IEC 60601-1-6:2010/AMD2:2020 – 3 –
© IEC 2020
INTRODUCTION TO AMENDMENT 2
The third edition of IEC 60601-1-6 was published in 2010 and amended in 2013. Since the
publication of IEC 60601-1-6:2010+A1:2013, 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 fourth edition of IEC 60601-1-6, which is presently targeted for publication
sometime after 2024.
Those issues selected for inclusion on the final "short list" to be addressed in Amendment 2
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, nine items were
presented to the National Committees present. All nine 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 2. All remaining issues have been placed on a "long list"
for consideration in the fourth edition of IEC 60601-1-6.
The "short list" of issues was documented in the design specification for Amendment 2. Because
these issues are closely related to the application of IEC 62366-1 to MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, the work was assigned to IEC/SC 62A-
ISO/TC 210 Joint Working Group (JWG) 4. JWG 4 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 document was
justified by the problem statement.
This amendment updates the references from the now obsolete IEC 62366:2007 to the current
USABILITY ENGINEERING PROCESS standard, IEC 62366-1:2015+A1:2020.
Because this is an amendment to IEC 60601-1-6:2010, the style in force at the time of
publication of IEC 60601-1-6 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. For example, references to
amendments take the following form: "IEC 60601-1:2005+A1:2012+A2:2020".
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 60601-1-6:2010/AMD2:2020
© IEC 2020
FOREWORD
Replace, in the existing fourth paragraph beginning with " This edition of IEC 60601-1-6 was
revised…", the reference to "IEC 62366" with "IEC 62366-1".
Replace, in the second dash of the existing ninth paragraph beginning with "In this collateral
standard, the following print types…", the reference to "IEC 62366" with "IEC 62366-1".
Replace the existing second paragraph before the last (including the footnote), beginning with
"To assist the user of this collateral standard…" and modified by Amendment 1, with the
following new paragraph and footnote:
To assist the user to implement the USABILITY ENGINEERING PROCESS, the Technical Report
1)
IEC TR 62366-2 [1] is available. IEC TR 62366-2 contains tutorial information to assist
MANUFACTURERS in complying with this standard. The Technical Report also goes beyond
safety-related aspects and offers more detailed descriptions of USABILITY ENGINEERING methods
that can be applied to the development of ME EQUIPMENT.
1)
Figures in square brackets refer to the Bibliography.
INTRODUCTION
Replace, in the second sentence before the last of the existing first paragraph, the term
OPERATOR-EQUIPMENT INTERFACE" with "OPERATOR INTERFACE".
"
Replace the last sentence of the existing first paragraph with the following new sentence:
The design of the OPERATOR INTERFACE to achieve safe use (adequate USABILITY) requires a
very different skill set than that of the technical implementation of that interface.
Replace, in the second paragraph, the reference "Figure A.1 of IEC 62366:2007" with
"Figure A.4 of IEC 62366-1:2015".
Replace, in the existing paragraph before the last, the last sentence with:
It should be noted that clinical investigations conducted according to ISO 14155 [2] and
USABILITY TESTS for FORMATIVE EVALUATION or SUMMATIVE EVALUATION according to this standard
are two fundamentally different activities and should not be confused.
1.1 * Scope
Replace, in the existing first paragraph, the words "design, VERIFY and VALIDATE USABILITY" with
"develop and evaluate the USABILITY".
Replace the existing third paragraph with the following new paragraph and note:
If the USABILITY ENGINEERING PROCESS detailed in this collateral standard has been complied
with, then the USABILITY of ME EQUIPMENT as it relates to BASIC SAFETY and ESSENTIAL
PERFORMANCE is presumed to be acceptable, unless there is OBJECTIVE EVIDENCE to the contrary.
NOTE Such OBJECTIVE EVIDENCE can subsequently originate from POST-PRODUCTION surveillance.
1.3.1 IEC 60601-1
Replace, in the first two bullet points of the existing
...