EN 60601-1:2006/A12:2014

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

2021: CLC legacy converted by DCLab NISOSTS

Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale

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

Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene zmogljivosti

General Information

• Status: Published
• Publication Date: 02-Oct-2014
• Withdrawal Date: 25-Mar-2015
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: CLC/TC 62 - Electrical equipment in medical practice
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 03-Oct-2014
• Completion Date: 03-Oct-2014
• 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/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 60601-1:2007/A12:2014 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Relations

• Amends: EN 60601-1:2006 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• Effective Date: 22-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1:2007/A12:2014
01-december-2014
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQH]PRJOMLYRVWL
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale
Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et
les performances essentielles
Ta slovenski standard je istoveten z: EN 60601-1:2006/A12:2014
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1:2007/A12:2014 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST EN 60601-1:2007/A12:2014

---------------------- Page: 2 ----------------------

SIST EN 60601-1:2007/A12:2014


EUROPEAN STANDARD EN 60601-1:2006/A12

NORME EUROPÉENNE

EUROPÄISCHE NORM
October 2014
ICS 11.040

English Version
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
Appareils électromédicaux - Partie 1: Exigences générales Medizinische elektrische Geräte - Teil 1: Allgemeine
pour la sécurité de base et les performances essentielles Festlegungen für die Sicherheit einschließlich der
wesentlichen Leistungsmerkmale
This amendment A12 modifies the European Standard EN 60601-1:2006; it was approved by CENELEC on 2014-09-26. 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-1:2006/A12:2014 E

---------------------- Page: 3 ----------------------

SIST EN 60601-1:2007/A12:2014
EN 60601-1:2006/A12:2014 - 2 -
Foreword
This document (EN 60601-1:2006/A12:2014) has been prepared by CLC/TC 62 “Electrical equipment
in medical practice”.
The following dates are fixed:
• latest date by which the document has to be implemented at (dop) 2015-03-26
national level by publication of an identical national
standard or by endorsement
(dow) 2015-03-26
• latest date by which the national standards conflicting with
the 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 [and/or CEN] 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, and supports essential requirements of EU Directive(s).
For the relationship with EU Directive(s) see informative Annexes ZZA and ZZB, which are an integral
part of this document.

---------------------- Page: 4 ----------------------

SIST EN 60601-1:2007/A12:2014
- 3 - EN 60601-1:2006/A12:2014
In Annex ZZ of EN 60601-1:2006 (available in EN 60601-1:2006/A1:2013), replace "Annex ZZ" by
"Annex ZZA" (two occurences) and "Table ZZ.1" by "Table ZZA.1 (three occurences)".
After Annex ZZA, add the following new Annex:
Annex ZZB
(informative)

Relationship between this European Standard and the Essential Requirements
of EU Directive 90/385/EEC on Active Implantable Medical Devices
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association to provide a means of conforming to the
Essential Requirements given in Annex I of the EC Directives 90/385/EEC as amended by
2007/47/EC.
General Guidance:
Once this stand
...