Medical device software - Software life-cycle processes

Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software.

Medizingeräte-Software - Software-Lebenszyklus-Prozesse

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

Définit les exigences du cycle de vie des logiciels de dispositifs médicaux. L'ensemble des processus, activités et tâches décrit dans la présente norme constitue un cadre commun pour les processus du cycle de vie des logiciels de dispositifs médicaux. S'applique au développement et à la maintenance des logiciels de dispositifs médicaux lorsque le logiciel est un dispositif médical ou lorsque le logiciel est incorporé ou fait partie intégrante du dispositif médical final. La présente norme ne couvre pas la validation et la mise sur le marché du dispositif médical, même lorsque le dispositif médical est intégralement constitué du logiciel.

Programska oprema za medicinske aparate – Procesi v življenjskem ciklu programske opreme (IEC 62304:2006)

Ta standard določa zahteve glede življenjskega cikla programske opreme za medicinske aparate. Nabor procesov, dejavnosti in opravil, opisanih v tem standardu, tvori skupno ogrodje za procese v življenjskem ciklu programske opreme za medicinske aparate. Ta standard se uporablja za razvoj in vzdrževanje programske opreme za medicinske aparate. Ta standard se lahko uporablja, kadar je programska oprema sama po sebi medicinskiaparat ali je vgrajen/sestavni del končne medicinskega aparata.

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oct 2006
Programska oprema za medicinske aparate – Procesi v življenjskem ciklu
programske opreme (IEC 62304:2006)
Medical device software - Software life-cycle processes (IEC 62304:2006)
ICS 13.020.60; 35.240.80 Referenčna številka
SIST EN 62304:2006(en)
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

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EN 62304

July 2006

ICS 11.040

English version

Medical device software -
Software life-cycle processes
(IEC 62304:2006)

Logiciels de dispositifs médicaux - Medizingeräte-Software -
Processus du cycle de vie du logiciel Software-Lebenszyklus-Prozesse
(CEI 62304:2006) (IEC 62304:2006)

This European Standard was approved by CENELEC on 2006-06-01. CENELEC members are bound to comply
with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard
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 Central Secretariat or to any CENELEC member.

This European Standard 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 Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 62304:2006 E

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EN 62304:2006 - 2 -
The text of document 62A/523/FDIS, future edition 1 of IEC 62304, prepared by a joint working group of
SC 62A, Common aspects of electrical equipment used in medical practice, of IEC technical committee
62, Electrical equipment in medical practice, and ISO Technical Committee 210, Quality management
and corresponding general aspects for medical devices, was submitted to the IEC-CENELEC parallel
vote and was approved by CENELEC as EN 62304 on 2006-06-01.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2007-03-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2009-06-01
In this standard the following print types are used:
– requirements and definitions: in roman type;
– informative material appearing outside of tables, such as notes, examples and references: in smaller
type. Normative text of tables is also in a smaller type;
– terms used throughout this standard that have been defined in Clause 3 and also given in the index: IN
An asterisk (*) as the first character of a title or at the beginning of a paragraph indicates that there is
guidance related to that item in Annex B.
Table C.5 was prepared by ISO/IEC JTC 1/SC 7, Software and system engineering.
Annex ZA has been added by CENELEC.
Endorsement notice
The text of the International Standard IEC 62304:2006 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 indicated:
IEC 60601-1-4 + A1 NOTE  Harmonized as EN 60601-1-4:1996 + A1:1999 (not modified).
IEC 61508-3 NOTE  Harmonized as EN 61508-3:2001 (not modified).
IEC 61010-1 NOTE  Harmonized as EN 61010-1:2001 (not modified).
ISO 9000 NOTE  Harmonized as EN ISO 9000:2005 (not modified).
ISO 9001 NOTE  Harmonized as EN ISO 9001:2000 (not modified).
ISO 13485 NOTE  Harmonized as EN ISO 13485:2003 (not modified).
IEC 60601-1-6 NOTE  Harmonized as EN 60601-1-6:2004 (not modified).

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- 3 - EN 62304:2006

Annex ZA

Normative references to international publications
with their corresponding European publications

The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For un

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