IEC 62304:2006

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.

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.

General Information

• Status: Published
• Publication Date: 08-May-2006
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 3 - TC 62/SC 62A/JWG 3
• Current Stage: PPUB - Publication issued
• Start Date: 15-Aug-2006
• Completion Date: 09-May-2006

Relations

• Amended By: IEC 62304:2006/AMD1:2015 - Amendment 1 - Medical device software - Software life cycle processes
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL IEC
STANDARD 62304
First edition
2006-05
Medical device software –
Software life cycle processes
This English-language version is derived from the original
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INTERNATIONAL IEC
STANDARD 62304
First edition
2006-05
Medical device software –
Software life cycle processes
© IEC 2006 Copyright - all rights reserved
No part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical,
including photocopying and microfilm, without permission in writing from the publisher.
International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
Telephone: [phone] Telefax: [phone] E-mail: [e-mail] Web: www.iec.ch
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62304  IEC:2006 – 3 –
CONTENTS
FOREWORD.7

INTRODUCTION.11

1 Scope.17

1.1 * Purpose .17

1.2 * Field of application .17

1.3 Relationship to other standards.17

1.4 Compliance .17
2 * Normative references .19
3 * Terms and definitions .19
4 * General requirements.27
4.1 * Quality management system.27
4.2 * RISK MANAGEMENT.29
4.3 * Software safety classification.29
5 Software development PROCESS .31
5.1 * Software development planning .31
5.2 * Software requirements analysis .35
5.3 * Software ARCHITECTURAL design .39
5.4 * Software detailed design .41
5.5 * SOFTWARE UNIT implementation and verification.41
5.6 * Software integration and integration testing .43
5.7 * SOFTWARE SYSTEM testing.47
5.8 * Software release .49
6 Software maintenance PROCESS .51
6.1 * Establish software maintenance plan .51
6.2 * Problem and modification analysis.51
6.3 * Modification implementation .53
7 * Software RISK MANAGEMENT PROCESS .55
7.1 * Analysis of software contributing to hazardous situations .55
7.2 RISK CONTROL measures .57
7.3 VERIFICATION of RISK CONTROL measures.57
7.4 RISK MANAGEMENT of software changes .59

8 * Software configuration management PROCESS.59
8.1 * Configuration identification .59
8.2 * Change control.61
8.3 * Configuration status accounting.61
9 * Software problem resolution PROCESS.61
9.1 Prepare PROBLEM REPORTS.61
9.2 Investigate the problem.63
9.3 Advise relevant parties .63
9.4 Use change control process.63
9.5 Maintain records .63
9.6 Analyse problems for trends .63
9.7 Verify software problem resolution .65
9.8 Test documentation contents .65

62304  IEC:2006 – 5 –
Annex A (informative) Rationale for the requirements of this standard.67

Annex B (informative) Guidance on the provisions of this standard .73

Annex C (informative) Relationship to other standards. 105

Annex D (informative) Implementation . 147

Bibliography . 151

Index of defined terms.153

Figure 1 – Overview of software development PROCESSES and ACTIVITIES.13
Figure 2 – Overview of software maintenance PROCESSES and ACTIVITIES.13
Figure B.1 – Example of partitioning of SOFTWARE ITEMS .83
Figure C.1 – Relationship of key MEDICAL DEVICE standards to IEC 62304 . 107
Figure C.2 – Software as part of the V-model . 111
Figure C.3 – Application of IEC 62304 with IEC 61010-1. 131

Table A.1 – Summary of requirements by software safety class .71
Table B.1 – Development (model) strategies as defined at ISO/IEC 12207.75
Table C.1 – Relationship to ISO 13485:2003 . 107
Table C.2 – Relationship to ISO 14971:2000 . 109
Table C.3 – Relationship to IEC 60601-1 . 115
Table C.4 – Relationship to IEC 60601-1-4 . 123
Table C.5 – Relationship to ISO/IEC 12207 . 135
Table D.1 – Checklist for small companies without a certified QMS. 149

62304  IEC:2006 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________
MEDICAL DEVICE SOFTWARE –
SOFTWARE LIFE CYCLE PROCESSES
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote

international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
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between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
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7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
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expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
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indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 62304 has been prepared by a joint working group of subcommittee
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,

MEDICAL DEVICES. Table C.5 was
Quality management and corresponding general aspects for
prepared by ISO/IEC JTC 1/SC 7, Software and system engineering.
It is published as a dual logo standard.
The text of this standard is based on the following documents:
FDIS Report on voting
62A/523/FDIS 62A/528/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table. In ISO, the standard has been approved by 23 P-members
out of 23 having cast a vote.
------
...

IEC 62304
Edition 1.1 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical device software – Software life cycle processes

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IEC 62304
Edition 1.1 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
colour
inside
Medical device software – Software life cycle processes

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.140 ISBN 978-2-8322-2765-7

IEC 62304
Edition 1.1 2015-06
CONSOLIDATED VERSION
REDLINE VERSION
colour
inside
Medical device software – Software life cycle processes

– 2 – IEC 62304:2006
+AMD1:2015 CSV  IEC 2015
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 8
1  Scope . 9
1.1  * Purpose . 9
1.2  * Field of application . 9
1.3  Relationship to other standards . 9
1.4  Compliance . 9
2  * Normative references . 10
3  * Terms and de finitions . 10
4  * General requirements . 15
4.1  * Quality management system . 15
4.2  * RISK MANAGEMENT . 16
4.3  * Software safety classification . 16
4.4  * LEGACY SOFTWARE . 18
5  Software development PROCESS . 19
5.1  * Software development planni ng . 19
5.2  * Software requirements analys is . 21
5.3  * Software ARCHITECTURAL design . 23
5.4  * Software detailed design . 24
5.5  * SOFTWARE UNIT implementation and verification . 25
5.6  * Software integration and integration testing . 25
5.7  * SOFTWARE SYSTEM testing . 27
5.8  * Software release . 28
6  Software maintenance PROCESS . 29
6.1  * Establish software maintenance plan . 29
6.2  * Problem and modification analysis . 30
6.3  * Modification implementation . 31
7  * Software RISK MANAGEMENT PROCESS . 31
7.1  * Analysis of software contributing to hazardous s i tuations . 31
7.2  RISK CONTROL measures . 32
7.3  VERIFICATION of RISK CONTROL measures . 32
7.4  RISK MANAGEMENT of software changes . 33
8  * Software configuration management PROCESS . 33
8.1  * Configuration identification . 33
8.2  * Change control . 33
8.3  * Configuration status accounting . 34
9  * Software problem resolution PROCESS . 34
9.1  Prepare PROBLEM REPORTS . 34
9.2  Investigate the problem . 35
9.3  Advise relevant parties . 35
9.4  Use change control process . 35
9.5  Maintain re c o rds . 35
9.6  Analyse problems for trends . 35
9.7  Verify software problem resolution . 35

+AMD1:2015 CSV  IEC 2015
9.8  Test documentation contents . 36
Annex A (informative) Rationale for the requirements of this standard . 37
Annex B (informative) Guidance on the provisions of this standard . 40
Annex C (informative) Relationship to other standards . 58
Annex D (informative) Implement ation . 84
Bibliography . . 86
Index of defined terms . 88

Figure 1 – Overview of software development PROCESSES and ACTIVITIES . 7
Figure 2 – Overview of software maintenance PROCESSES and ACTIVITIES . 7
Figure 3 – Assigning software safety classification . 16
Figure B.2 – Pictorial representation of the relationship of HAZARD, sequence of
events, HAZARDOUS SITUATION, and HARM – from ISO 14971:2007 Annex E . 44
Figure B.1 – Example of partitioning of SOFTWARE ITEMS . 46
Figure C.1 – Relationship of key MEDICAL DEVICE standards to IEC 62304 . 59
Figure C.2 – Software as part of the V-model . 62
Figure C.3 – Application of IEC 62304 with IEC 61010-1 . 72

Table A.1 – Summary of requirements by software safety class . 39
Table B.1 – Development (model) strategies as defined in ISO/IEC 12207 . 41
Table C.1 – Relationship to ISO 13485:2003 . 60
Table C.2 – Relationship to ISO 14971:2000 2007 . 61
Table C.3 – Relationship to IEC 60601-1 . 64
Table C.4 – Relationship to IEC 60601-4 .
Table C.5 – Relationship to ISO/IEC 12207 . 74
Table D.1 – Checklist for small companies without a certified QMS . 85

– 4 – IEC 62304:2006
+AMD1:2015 CSV  IEC 2015
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL DEVICE SOFTWARE –
SOFTWARE LIFE CYCLE PROCESSES
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9)
...

NORME CEI
INTERNATIONALE 62304
Première édition
2006-05
Logiciels de dispositifs médicaux –
Processus du cycle de vie du logiciel

Cette version française découle de la publication d’origine
bilingue dont les pages anglaises ont été supprimées.
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Numéro de référence
CEI 62304:2006(F)
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INTERNATIONALE 62304
Première édition
2006-05
Logiciels de dispositifs médicaux –
Processus du cycle de vie du logiciel

© IEC 2006 Droits de reproduction réservés
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International Electrotechnical Commission, 3, rue de Varembé, PO Box 131, CH-1211 Geneva 20, Switzerland
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– 2 – 62304  CEI:2006
SOMMAIRE
AVANT-PROPOS .6

INTRODUCTION.10

1 Domaine d'application.16

1.1 *Objet.16

1.2 * Domaine d'application .16

1.3 Relations avec d'autres normes .16

1.4 Conformité .16
2 * Références normatives.18
3 * Termes et définitions .18
4 * Exigences générales .26
4.1 * Système de management de la qualité.26
4.2 * GESTION DES RISQUES .28
4.3 * Classification de sécurité du logiciel .28
5 PROCESSUS de développement du logiciel .30
5.1 * Planification du développement du logiciel.30
5.2 * Analyses des exigences du logiciel.34
5.3 * Conception ARCHITECTURALE du logiciel .38
5.4 * Conception détaillée du logiciel .40
5.5 * Mise en œuvre et vérification des UNITÉS LOGICIELLES .40
5.6 * Intégration et essai d'intégration du logiciel.42
5.7 * Essais du SYSTÈME LOGICIEL .46
5.8 * Diffusion du logiciel .48
6 PROCESSUS de maintenance du logiciel .50
6.1 * Etablissement du plan de maintenance du logiciel .50
6.2 * Analyse des problèmes et des modifications.50
6.3 * Mise en œuvre de la modification .52
7 * PROCESSUS DE GESTION DES RISQUES du logiciel .54
7.1 * Analyse du logiciel en termes de contribution à des situations dangereuses .54
7.2 Mesures DE MAÎTRISE DU RISQUE .56
7.3 VÉRIFICATION des mesures de MAÎTRISE DU RISQUE.56
7.4 GESTION DES RISQUES des modifications du logiciel.58

8 * PROCESSUS de gestion de configuration du logiciel.58
8.1 * Identification de la configuration .58
8.2 * Maîtrise des modifications .60
8.3 * Documentation relative à l'état de la configuration .60
9 * PROCESSUS de résolution de problème logiciel .60
9.1 Elaboration des RAPPORTS DE PROBLÈME.60
9.2 Etude du problème .62
9.3 Information des parties concernées .62
9.4 Utilisation du processus de la maîtrise des modifications .62
9.5 Conservation des enregistrements .62
9.6 Analyse de tendance pour les problèmes .62
9.7 VÉRIFICATION de la résolution des problèmes du logiciel .64
9.8 Teneur de la documentation d'essai.64

– 4 – 62304  CEI:2006
Annexe A (informative) Justification des exigences de la présente norme .66

Annexe B (informative) Lignes directrices relatives aux dispositions de la présente norme.72

Annexe C (informative) Relations avec d'autres normes . 104

Annexe D (informative) Mise en œuvre. 146

Bibliographie . 150

Index des termes définis . 152

Figure 1 – Présentation générale des PROCESSUS et ACTIVITÉS de développement de
logiciels .12
Figure 2 – Présentation générale des PROCESSUS et ACTIVITÉS de maintenance de
logiciels .12
Figure B.1 – Exemple de découpage d'ÉLÉMENTS LOGICIELS .82
Figure C.1 – Relation des principales normes de DISPOSITIFS MÉDICAUX avec la
CEI 62304. 106
Figure C.2 – Logiciel comme partie du modèle en V . 110
Figure C.3 – Application de la CEI 62304 avec la CEI 61010-1 . 130

Tableau A.1 – Récapitulatif des exigences par classe de sécurité de logiciel .70
Tableau B.1 – Stratégies (modèle) de développement telles que définies dans
l’ISO/CEI 12207 .74
Tableau C.1 – Relation avec l'ISO 13485:2003 . 106
Tableau C.2 – Relation avec l'ISO 14971:2000 . 108
Tableau C.3 – Relation avec la CEI 60601-1. 114
Tableau C.4 – Relation avec la CEI 60601-1-4. 122
Tableau C.5 – Relation avec l’ISO/CEI 12207 . 134
Tableau D.1 – Liste de contrôle pour les petites entreprises sans SMQ certifié . 148

– 6 – 62304  CEI:2006
COMMISSION ÉLECTROTECHNIQUE INTERNATIONALE

____________
LOGICIELS DE DISPOSITIFS MÉDICAUX –

PROCESSUS DU CYCLE DE VIE DU LOGICIEL

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...

IEC 62304
Edition 1.0 2006-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical device software – Software life cycle processes

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

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IEC 62304
Edition 1.0 2006-05
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical device software – Software life cycle processes

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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XC
CODE PRIX
ICS 11.040 ISBN 2-8318-8637-6
– 2 – 62304 © IEC:2006
62304  IEC:2006 – 3 –
CONTENTS
FOREWORD.4
INTRODUCTION.6

1 Scope.9
1.1 * Purpose .9
1.2 * Field of application .9
1.3 Relationship to other standards.9
1.4 Compliance .9
2 * Normative references .10
3 * Terms and definitions .10
4 * General requirements.14
4.1 * Quality management system.14
4.2 * RISK MANAGEMENT.15
4.3 * Software safety classification.15
5 Software development PROCESS .16
5.1 * Software development planning .16
5.2 * Software requirements analysis .18
5.3 * Software ARCHITECTURAL design .20
5.4 * Software detailed design .21
5.5 * SOFTWARE UNIT implementation and verification.21
5.6 * Software integration and integration testing .22
5.7 * SOFTWARE SYSTEM testing.24
5.8 * Software release .25
6 Software maintenance PROCESS .26
6.1 * Establish software maintenance plan .26
6.2 * Problem and modification analysis.26
6.3 * Modification implementation .27
7 * Software RISK MANAGEMENT PROCESS .28
7.1 * Analysis of software contributing to hazardous situations .28
7.2 RISK CONTROL measures .29
7.3 VERIFICATION of RISK CONTROL measures.29
7.4 RISK MANAGEMENT of software changes .30
8 * Software configuration management PROCESS.30
8.1 * Configuration identification .30
8.2 * Change control.31
8.3 * Configuration status accounting.31
9 * Software problem resolution PROCESS.31
9.1 Prepare PROBLEM REPORTS.31
9.2 Investigate the problem.32
9.3 Advise relevant parties .32
9.4 Use change control process.32
9.5 Maintain records .32
9.6 Analyse problems for trends .32
9.7 Verify software problem resolution .33
9.8 Test documentation contents .33

62304 © IEC:2006 – 3 –
62304  IEC:2006 – 5 –
Annex A (informative) Rationale for the requirements of this standard.34
Annex B (informative) Guidance on the provisions of this standard .37
Annex C (informative) Relationship to other standards.53
Annex D (informative) Implementation .74

Bibliography .

Index of defined terms.77

Figure 1 – Overview of software development PROCESSES and ACTIVITIES.7
Figure 2 – Overview of software maintenance PROCESSES and ACTIVITIES.7
Figure B.1 – Example of partitioning of SOFTWARE ITEMS .42
Figure C.1 – Relationship of key MEDICAL DEVICE standards to IEC 62304 .54
Figure C.2 – Software as part of the V-model .56
Figure C.3 – Application of IEC 62304 with IEC 61010-1.66

Table A.1 – Summary of requirements by software safety class .36
Table B.1 – Development (model) strategies as defined at ISO/IEC 12207.38
Table C.1 – Relationship to ISO 13485:2003 .54
Table C.2 – Relationship to ISO 14971:2000 .55
Table C.3 – Relationship to IEC 60601-1 .58
Table C.4 – Relationship to IEC 60601-1-4 .62
Table C.5 – Relationship to ISO/IEC 12207 .68
Table D.1 – Checklist for small companies without a certified QMS.75

– 4 – 62304 © IEC:2006
62304  IEC:2006 – 7 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL DEVICE SOFTWARE –
SOFTWARE LIFE CYCLE PROCESSES
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
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misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications
...

IEC 62304
Edition 1.1 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical device software – Software life cycle processes

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

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.

Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
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et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
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About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.

About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.

IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary

(IEV) online.
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IEC publications issued between 2002 and 2015. Some
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If you wish to give us your feedback on this publication or TC 37, 77, 86 and CISPR.

need further assistance, please contact the Customer Service

Centre: [e-mail].
A propos de l'IEC
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Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.

A propos des publications IEC
Le contenu technique des publications IEC est constamment revu. Veuillez vous assurer que vous possédez l’édition la
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Si vous désirez nous donner des commentaires sur cette
publication ou si vous avez des questions contactez-nous:
[e-mail].
IEC 62304
Edition 1.1 2015-06
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical device software – Software life cycle processes

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

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.140 ISBN 978-2-8322-2765-7

IEC 62304
Edition 1.1 2015-06
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical device software – Software life cycle processes

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

– 2 – IEC 62304:2006+AMD1:2015 CSV
 IEC 2015
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
INTRODUCTION to Amendment 1 . 8
1 Scope . 9
1.1 * Purpose . 9
1.2 * Field of application . 9
1.3 Relationship to other standards . 9
1.4 Compliance . 10
2 * Normative references . 10
3 * Terms and definitions . 10
4 * General requirements . 16
4.1 * Quality management system . 16
4.2 * RISK MANAGEMENT . 16
4.3 * Software safety classification . 16
4.4 * LEGACY SOFTWARE . 18
5 Software development PROCESS . 19
5.1 * Software development planning . 19
5.2 * Software requirements analysis . 21
5.3 * Software ARCHITECTURAL design . 23
5.4 * Software detailed design . 24
5.5 * SOFTWARE UNIT implementation and verification . 25
5.6 * Software integration and integration testing . 26
5.7 * SOFTWARE SYSTEM testing . 27
5.8 * Software RELEASE for utilization at a SYSTEM level . 28
6 Software maintenance PROCESS . 29
6.1 * Establish software maintenance plan . 29
6.2 * Problem and modification analysis . 30
6.3 * Modification implementation . 31
7 * Software RISK MANAGEMENT PROCESS . 31
7.1 * Analysis of software contributing to hazardous situations . 31
7.2 RISK CONTROL measures . 32
7.3 VERIFICATION of RISK CONTROL measures . 32
7.4 RISK MANAGEMENT of software changes . 33
8 * Software configuration management PROCESS. 33
8.1 * Configuration identification . 33
8.2 * Change control . 34
8.3 * Configuration status accounting . 34
9 * Software problem resolution PROCESS . 34
9.1 Prepare PROBLEM REPORTS . 34
9.2 Investigate the problem. 35
9.3 Advise relevant parties . 35
9.4 Use change control process . 35
9.5 Maintain records . 35
9.6 Analyse problems for trends . 35
9.7 Verify software problem resolution . 36

 IEC 2015
9.8 Test documentation contents . 36
Annex A (informative) Rationale for the requirements of this standard. 37
Annex B (informative) Guidance on the provisions of this standard . 40
Annex C (informative) Relationship to other standards . 58
Annex D (informative) Implementation . 84
Bibliography . 86
Index of defined terms . 88

Figure 1 – Overview of software development PROCESSES and ACTIVITIES . 7
Figure 2 – Overview of software maintenance PROCESSES and ACTIVITIES . 7
Figure 3 – Assigning software safety classification . 16
Figure B.2 – Pictorial representation of the relationship of HAZARD, sequence of events,
HAZARDOUS SITUATION, and HARM – from ISO 14971:2007 Annex E . 44
Figure B.1 – Example of partitioning of SOFTWARE ITEMS . 46
Figure C.1 – Relationship of key MEDICAL DEVICE standards to IEC 62304 . 59
Figure C.2 – Software as part of the V-model . 62
Figure C.3 – Application of IEC 62304 with IEC 61010-1 . 72

Table A.1 – Summary of requirements by software safety class . 39
Table B.1 – Development (model) strategies as defined in ISO/IEC 12207 . 41
Table C.1 – Relationship to ISO 13485:2003 . 60
Table C.2 – Relationship to ISO 14971:2000 2007 . 61
Table C.3 – Relationship to IEC 60601-1 . 64
Table C.4 – Relationship to IEC 60601-1-4 .
Table C.5 – Relationship to ISO/IEC 12207:2008 . 74
Table D.1 – Checklist for small companies without a certified QMS . 85

– 4 – IEC 62304:2006+AMD1:2015 CSV
 IEC 2015
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL DEVICE SOFTWARE –
SOFTWARE LIFE CYCLE PROCESSES
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organiza
...