Medical device software - Software life-cycle processes

PWI created for possible future // procedures

Medizingeräte-Software - Software-Lebenszyklus-Prozesse

Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel

Programska oprema za medicinske aparate - Procesi v življenjskem ciklu programske opreme - Dopolnilo A1

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EN 62304:2006/A1:2015
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SIST EN 62304:2006/A1:2015
Programska oprema za medicinske aparate - Procesi v življenjskem ciklu
programske opreme - Dopolnilo A1
Medical device software - Software life-cycle processes
Medizingeräte-Software - Software-Lebenszyklus-Prozesse
Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel
Ta slovenski standard je istoveten z: EN 62304:2006/A1:2015
13.020.60 Življenjski ciklusi izdelkov Product life-cycles
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
SIST EN 62304:2006/A1:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 62304:2006/A1:2015

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SIST EN 62304:2006/A1:2015



October 2015
ICS 11.040

English Version
Medical device software - Software life-cycle processes
(IEC 62304:2006/A1:2015)
Logiciels de dispositifs médicaux - Processus du cycle de Medizingeräte-Software - Software-Lebenszyklus-Prozesse
vie du logiciel (IEC 62304:2006/A1:2015)
(IEC 62304:2006/A1:2015)
This amendment A1 modifies the European Standard EN 62304:2006; it was approved by CENELEC on 2015-07-31. 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 62304:2006/A1:2015 E

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SIST EN 62304:2006/A1:2015
EN 62304:2006/A1:2015
European Foreword
The text of document 62A/1007/FDIS, future IEC 62304:2006/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 62304:2006/A1:2015.

The following dates are fixed:
• latest date by which the document has to be (dop) 2016-05-01
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-07-31
• 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 93/42/EEC, 98/79/EC, 90/385/EEC see informative Annex ZZ,
included in EN 62304:2006/corrigendum Nov. 2008.
Endorsement notice
The text of the International Standard IEC 62304:2006/A1:2015 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
Replace the existing references with the following:

IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006.
IEC 60601-1:2005/AMD1:2012 NOTE Harmonized as EN 60601-1:2006/A1:2013.
IEC 60601-1-4:1996 NOTE Harmonized as EN 60601-1-4:1996.
IEC 60601-1-4:1996/AMD1:1999 NOTE Harmonized as EN 60601-1-4:1996/A1:1999.
IEC 60601-1-6 NOTE Harmonized as EN 60601-1-6.
IEC 61508-3 NOTE Harmonized as EN 61508-3.
IEC 61010-1:2010 NOTE Harmonized as EN 61010-1:2010.
ISO 9000:2005 NOTE Harmonized as EN ISO 9000:2005.
ISO 9001:2008 NOTE Harmonized as E

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