EN 60601-1-11:2015/A1:2021

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

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

Medizinische elektrische Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und medizinische elektrische Systeme für die medizinische Versorgung in häuslicher Umgebung

Appareils électromédicaux - Partie 1-11: Exigences générales pour la sécurité de base et les performances essentielles - Norme Collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux utilisés dans l’environnement des soins à domicile

Medicinska električna oprema - 1-11. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zahteve za medicinsko električno opremo in medicinske električne sisteme, ki se uporabljajo v okolju domače zdravstvene oskrbe - Dopolnilo A1 (IEC 60601-1-11:2015/A1:2020)

General Information

• Status: Published
• Publication Date: 15-Jul-2021
• ICS: 11.020.10 - Health care services in general
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 16-Jul-2021
• Completion Date: 16-Jul-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 60601-1-11:2015/A1:2021 - 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 (IEC 60601-1-11:2015/A1:2020)

Relations

• Amends: EN 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
• Effective Date: 29-Aug-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2021
Medicinska električna oprema - 1-11. del: Splošne zahteve za osnovno varnost in
bistvene lastnosti - Spremljevalni standard: Zahteve za medicinsko električno
opremo in medicinske električne sisteme, ki se uporabljajo v okolju domače
zdravstvene oskrbe - Dopolnilo A1 (IEC 60601-1-11:2015/A1:2020)
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
(IEC 60601-1-11:2015/A1:2020)
Medizinische elektrische Geräte - Teil 1-11: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen
an medizinische elektrische Geräte und medizinische elektrische Systeme für die
medizinische Versorgung in häuslicher Umgebung (IEC 60601-1-11:2015/A1:2020)
Appareils électromédicaux - Partie 1-11: Exigences générales pour la sécurité de base et
les performances essentielles - Norme Collatérale: Exigences pour les appareils
électromédicaux et les systèmes électromédicaux utilisés dans l'environnement des soin
(IEC 60601-1-11:2015/A1:2020)
Ta slovenski standard je istoveten z: EN 60601-1-11:2015/A1:2021
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 60601-1-11:2015/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2021
ICS 11.020.10; 11.040.01
English Version
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
(IEC 60601-1-11:2015/A1:2020)
Appareils électromédicaux - Partie 1-11: Exigences Medizinische elektrische Geräte - Teil 1-11: Besondere
générales pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles - Norme Collatérale: Exigences pour les wesentlichen Leistungsmerkmale - Ergänzungsnorm:
appareils électromédicaux et les systèmes électromédicaux Anforderungen an medizinische elektrische Geräte und
utilisés dans l'environnement des soins à domicile medizinische elektrische Systeme für die medizinische
(IEC 60601-1-11:2015/A1:2020) Versorgung in häuslicher Umgebung
(IEC 60601-1-11:2015/A1:2020)
This amendment A1 modifies the European Standard EN 60601-1-11:2015; 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 60601-1-11:2015/A1:2021 E

European foreword
The text of document 62A/1395/FDIS, future IEC 60601-1-11/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) 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 60601-1-11:2015/A1:2020 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:
IEC 62368-1:2018 NOTE Harmonized as EN IEC 62368-1:2020 (not modified)
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
CISPR 11 2009 Industrial, scientific and medical equipment - -
- Radio-frequency disturbance
characteristics - Limits and methods of
measurement
IEC 60068-2-27 2008 Environmental testing - Part 2-27: Tests - EN 60068-2-27 2009
Test Ea and guidance: Shock
IEC 60068-2-31 2008 Environmental testing - Part 2-31: Tests - EN 60068-2-31 2008
Test Ec: Rough handling shocks, primarily
for equipment-type specimens
IEC 60068-2-64 2008 Environmental testing - Part 2-64: Tests - EN 60068-2-64 2008
Test Fh: Vibration, broadband random and
guidance
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
enclosures (IP Code)
- -  + corrigendum May 1993
+ A1 1999  + A1 2000
+ A2 2013  + A2 2013
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
Publication Year Title EN/HD Year
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety and
essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
+ A1 2020  + A1 2021
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety and
essential performance - Collateral
standard: Usability
+ A1 2013  + A1 2015
+ A2 2020  + A2 2021
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  + A2 2021
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
+ A1 2020  + A1 2020
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 7000 - Graphical symbols for use on equipment - - -
Registered symbols
ISO 7010 2019 Graphical symbols - Safety colours and - -
safety signs - Registered safety signs
ISO 15223-1 2016 Medical devices - Symbols to be used with EN ISO 15223-1 2016
medical device labels,
labelling and information to be supplied -
Part 1: General requirements
IEC 60601-1-11
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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

Appareils électromédicaux –
Partie 1-11: Exigences générales pour la sécurité de base et les performances

essentielles – Norme Collatérale: Exigences pour les appareils électromédicaux

et les systèmes électromédicaux utilisés dans l’environnement des soins à

domicile
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.020.10; 11.040.01 ISBN 978-2-8322-8623-4

– 2 – IEC 60601-1-11:2015/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, and ISO subcommittee 3: Respiratory devices and related equipment used for
patient care of ISO technical committee 121: Anaesthetic and respiratory equipment.
It is published as a double logo amendment.
The text of this amendment is based on the following documents of IEC:
FDIS Report on voting
62A/1395/FDIS 62A/1410/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. In ISO, the amendment has been approved by 15 P
members out of 15 having cast a vote.
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 60601-1-11:2015/AMD1:2020 – 3 –
© IEC 2020
INTRODUCTION TO AMENDMENT 1
The second edition of IEC 60601-1-11 was published in 2015. Since the publication of
IEC 60601-1-11:2015, 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 third
edition of IEC 60601-1-11, 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, four items were
presented to the National Committees present. All four 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 third edition of IEC 60601-1-11.
The "short list" of issues was documented in the design specification for Amendment 1. As
IEC 60601-1-11 was jointly developed with ISO/TC 121/SC 3, the work was assigned to
IEC/SC 62A-ISO/TC 121/SC 3 Joint Working Group (JWG) 6. JWG 6 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 60601-1-11:2015, the style in force at the time of
publication of IEC 60601-1-11 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 i
...