SIST EN 60601-1-6:2010/A1:2015

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

2013-10-02 - BT146_DG9211 extended DOW to 2018-12-31
2013-08-13 - Negative assessment from Consultant

Medizinische elektrische Geräte - Teil 1-6: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm: Gebrauchstauglichkeit

Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Aptitude à l'utilisation

Medicinska električna oprema - 1-6. del: Splošne zahteve za osnovno varnost in bistvene lastnosti - Spremljevalni standard: Uporabnost - Dopolnilo A1

General Information

• Status: Published
• Publication Date: 13-Aug-2015
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 15-Jun-2015
• Due Date: 20-Aug-2015
• Completion Date: 14-Aug-2015
• 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
• Ref Project: EN 60601-1-6:2010/A1:2015 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

Relations

• Amends: SIST EN 60601-1-6:2010 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)
• Effective Date: 01-Sep-2015
• Amends: SIST EN 60601-1-6:2010 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability (IEC 60601-1-6:2010)
• Effective Date: 29-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 60601-1-6:2010/A1:2015
01-september-2015
0HGLFLQVNDHOHNWULþQDRSUHPDGHO6SORãQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWL6SUHPOMHYDOQLVWDQGDUG8SRUDEQRVW'RSROQLOR$
Medical electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability
Medizinische elektrische Geräte - Teil 1-6: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale - Ergänzungsnorm:
Gebrauchstauglichkeit
Appareils électromédicaux - Partie 1-6: Exigences générales pour la sécurité de base et
les performances essentielles - Norme collatérale: Aptitude à l'utilisation
Ta slovenski standard je istoveten z: EN 60601-1-6:2010/A1:2015
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1-6:2010/A1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 60601-1-6:2010/A1:2015

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SIST EN 60601-1-6:2010/A1:2015


EUROPEAN STANDARD EN 60601-1-6:2010/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040

English Version
Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard:
Usability
(IEC 60601-1-6:2010/A1:2013)
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
(IEC 60601-1-6:2010/A1:2013) (IEC 60601-1-6:2010/A1:2013)
This amendment A1 modifies the European Standard EN 60601-1-6:2010; it was approved by CENELEC on 2015-04-14. 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
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
 Ref. No. EN 60601-1-6:2010/A1:2015 E

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SIST EN 60601-1-6:2010/A1:2015
EN 60601-1-6:2010/A1:2015
Foreword
The text of document 62A/890/FDIS, future IEC 60601-1-6:2010/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
EN 60601-1-6:2010/A1:2015.

The following dates are fixed:
• latest date by which the document has to be (dop) 2016-01-14
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-12-31
• 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.

For the relationship with EU Directive 90/385/EEC, see informative Annex ZZ, which is an integral part
of this document.
For the relationship with EU Directive 93/42/EEC, see informative Annex ZZ, included in
EN 60601-1-6:2010.
Endorsement notice
The text of the International Standard IEC 60601-1-6:2010/A1:2013 was approved by CENELEC as a
European Standard without any modification.
2

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SIST EN 60601-1-6:2010/A1:2015
EN 60601-1-6:2010/A1:2015
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.

NOTE 1 When 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

Replacement in Annex ZA of EN 60601-1-6:2010:

Publication Year Title EN/HD Year
Replace the existing references to IEC 60601-1, IEC 60601-1-8 and IEC 62366 by the
following new references:
IEC 60601-1 2005 Medical electrical equipment - EN 60601-1 2006
Part 1: General requirements for basic + corr. March 2010
safety and essential performance
+A1 2012  +A1 2013
+A1/AC 2014
  +A12 2014
IEC 60601-1-8 2006 Medical electrical equipment - EN 60601-1-8 2007
Part 1-8: General requirements for basic + corr. March 2010
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
+A1/AC 2014
IEC 62366 2007 Medical devices - Application of usability EN 62366 2008
engineering to medical devices
+A1 2014  A1 2015


3

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SIST EN 60601-1-6:2010/A1:2015
EN 60601-1-6:2010/A1:2015
Annex ZZ
(informative)

Coverage of Essential Requirements of EU Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association, and within its scope the Standard covers all
relevant essential requirements given in Annex 1 of EU Directive 90/385/EEC of 20 June 1990 relating
to active implantable medical devices.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EU Directives can be applied to the products falling within
the scope of this standard.

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SIST EN 60601-1-6:2010/A1:2015



IEC 60601-1-6

®


Edition 3.0 2013-10




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE




AMENDMENT 1

AMENDEMENT 1





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

PRICE CODE
INTERNATIONALE

CODE PRIX F


ICS 11.040 ISBN 978-2-8322-1132-8



Warning! Make sure that you obtained this publication from an authorized distributor.

Attention! Veuillez vous assurer que vous avez obtenu cette publication via un distributeur agréé.

® Registered trademark of the International Electrotechnical Commission
Marque déposée de la Commission Electrotechnique Internationale

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SIST EN 60601-1-6:2010/A1:2015
– 2 – 60601-1-6 Amend.1 © IEC:2013
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/890/FDIS 62A/898/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.
_____________

INTRODUCTION TO THE AMENDMENT
The third edition of IEC 60601-1-6 was published in 2010. The third edition created a bridge
that enables a MANUFACTURER to conform to the requirements in IEC 60601-1 that make
normative reference to IEC 60601-1-6 by employing a USABILITY ENGINEERING PROCESS
complying with IEC 62366:2007. However, IEC 62366 contains certain life-cycle proce
...