EN 60601-1-12:2015/A1:2020

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

2020-10-13:JO-CLC/TC 62 Decision  2019-05-21/22 in Oslo to remove the link to the published standard

Medizinische elektrische Geräte - Teil 1-12: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen an medizinische elektrische Geräte und medizinische elektrische Systeme in der Umgebung für den Notfalleinsatz

Appareils électromédicaux - Partie 1-12: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l'environnement des services médicaux d'urgence

Medicinska električna oprema - 1-12. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Zahteve za elektromedicinsko opremo in elektromedicinske sisteme, namenjene za uporabo v okolju nujne medicinske pomoči - Dopolnilo A1 (IEC 60601-1-12:2014/A1:2020)

General Information

• Status: Published
• Publication Date: 03-Sep-2020
• ICS: 11.040 - Medical equipment
• 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: 04-Sep-2020
• Completion Date: 04-Sep-2020
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• 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 60601-1-12:2015/A1:2020 - 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 (IEC 60601-1-12:2014/A1:2020)

Relations

• Amends: EN 60601-1-12:2015 - 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
• Effective Date: 23-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2020
Medicinska električna oprema - 1-12. del: Splošne zahteve za osnovno varnost in
bistvene lastnosti - Spremljevalni standard: Zahteve za elektromedicinsko opremo
in elektromedicinske sisteme, namenjene za uporabo v okolju nujne medicinske
pomoči - Dopolnilo A1 (IEC 60601-1-12:2014/A1:2020)
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 (IEC 60601-1-12:2014/A1:2020)
Medizinische elektrische Geräte - Teil 1-12: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Anforderungen
an medizinische elektrische Geräte und medizinische elektrische Systeme in der
Umgebung für den Notfalleinsatz (IEC 60601-1-12:2014/A1:2020)
Appareils électromédicaux - Partie 1-12: Exigences générales pour la sécurité de base
et les performances essentielles - Norme collatérale: Exigences pour les appareils
électromédicaux et les systèmes électromédicaux destinés à être utilisés dans
l'environnement des services médicaux d'urgence (IEC 60601-1-12:2014/A1:2020)
Ta slovenski standard je istoveten z: EN 60601-1-12:2015/A1:2020
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 60601-1-12:2015/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2020
ICS 11.040
English Version
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
(IEC 60601-1-12:2014/A1:2020)
Appareils électromédicaux - Partie 1-12: Exigences Medizinische elektrische Geräte - Teil 1-12: Allgemeine
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
destinés à être utilisés dans l'environnement des services medizinische elektrische Systeme in der Umgebung für den
médicaux d'urgence Notfalleinsatz
(IEC 60601-1-12:2014/A1:2020) (IEC 60601-1-12:2014/A1:2020)
This amendment A1 modifies the European Standard EN 60601-1-12:2015; 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
© 2020 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-1-12:2015/A1:2020 E

European foreword
The text of document 62A/1396/FDIS, future IEC 60601-1-12/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) 2021-05-26
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2023-08-26
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.
This document has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association.
Endorsement notice
The text of the International Standard IEC 60601-1-12:2014/A1:2020 was approved by CENELEC as
a European Standard without any modification.

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.
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 —
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 —
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 —
Under preparation. Stage at time of publication: EN 60601-1:2006/FprA2:2020.
Under preparation. Stage at time of publication: EN 60601-1-2:2015/FprA1:2020.
Under preparation. Stage at time of publication: EN 60601-1-6:2010/FprA2:2020.
Publication Year Title EN/HD Year
IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: EN 60601-1-8 2007
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
- -  + corrigendum Mar. 2010
+ A1 2012  + A1 2013
- -  + AC 2014
- -  + A11 2017
+ A2 2020  +A2 —
IEC 60601-1-11 2015 Medical electrical equipment - Part 1-11: EN 60601-1-11 2015
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 +A1 —
ISO 7010 2019 Graphical symbols - Safety colours and - -
safety signs - Registered safety signs

Under preparation. Stage at time of publication: EN 60601-1-8:2007/FprA2:2020.
Under preparation. Stage at time of publication: EN 60601-1-11:2015/FprA2:2020.
IEC 60601-1-12
Edition 1.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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
Appareils électromédicaux –
Partie 1-12: Exigences générales pour l
...