EN 62366:2008/A1:2015

Medical devices - Application of usability engineering to medical devices

Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte

Dispositifs médicaux - Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux

Medicinske naprave – Izvedba tehnik uporabe pri medicinskih napravah - Dopolnilo A1

General Information

• Status: Withdrawn
• Publication Date: 21-May-2015
• Withdrawal Date: 13-Apr-2018
• 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: 9960 - Withdrawal effective - Withdrawal
• Start Date: 31-Mar-2018
• Completion Date: 31-Mar-2018
• Directive: 2006/95/EC - Directive 2006/95/EC of the European Parliament and of the Council of 12 December 2006 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits (codified version)
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic 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 62366:2008/A1:2015 - Medical devices - Application of usability engineering to medical devices

Relations

• Replaced By: EN 62366-1:2015 - Medical devices - Part 1: Application of usability engineering to medical devices
• Effective Date: 28-Jan-2023
• Amends: EN 62366:2008 - Medical devices - Application of usability engineering to medical devices
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 62366:2008/A1:2015
01-september-2015
Medicinske naprave – Izvedba tehnik uporabe pri medicinskih napravah -
Dopolnilo A1
Medical devices - Application of usability engineering to medical devices
Medizinprodukte - Anwendung der Gebrauchstauglichkeit auf Medizinprodukte
Dispositifs médicaux - Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs
médicaux
Ta slovenski standard je istoveten z: EN 62366:2008/A1:2015
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 62366:2008/A1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 62366:2008/A1:2015

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SIST EN 62366:2008/A1:2015


EUROPEAN STANDARD EN 62366:2008/A1

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2015
ICS 11.040

English Version
Medical devices - Application of usability engineering to medical
devices
(IEC 62366:2007/A1:2014)
Dispositifs médicaux - Application de l'ingénierie de Medizinprodukte - Anwendung der Gebrauchstauglichkeit
l'aptitude à l'utilisation aux dispositifs médicaux auf Medizinprodukte
(IEC 62366:2007/A1:2014) (IEC 62366:2007/A1:2014)
This amendment A1 modifies the European Standard EN 62366:2008; 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 62366:2008/A1:2015 E

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SIST EN 62366:2008/A1:2015
EN 62366:2008/A1:2015
Foreword
The text of document 62A/889/FDIS, future IEC 62366:2007/A1, prepared by SC 62A "Common
aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in
medical practice" and ISO/TC 210 "Quality management and corresponding general aspects for
medical devices" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN 62366:2008/A1:2015.

The following dates are fixed:
(dop) 2016-01-14
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2018-04-14
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 93/42/EEC, see informative Annex ZZ, included in
EN 62366:2008.

This standard covers the Principle Elements of the Safety Objectives for Electrical Equipment
Designed for Use within Certain Voltage Limits (LVD - 2006/95/EC).

Endorsement notice
The text of the International Standard IEC 62366:2007/A1:2014 was approved by CENELEC as a
European Standard without any modification.
2

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SIST EN 62366:2008/A1:2015



IEC 62366


Edition 1.0 2014-01




INTERNATIONAL



STANDARD




NORME



INTERNATIONALE




A MENDMENT 1

AM ENDEMENT 1





Medical devices – Application of usability engineering to medical devices



Dispositifs médicaux – Application de l'ingénierie de l'aptitude à l'utilisation aux

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