IEC TR 80002-3:2014
(Main)Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
IEC TR 80002-3:2014 which is a technical report (TR), provides the description of software life cycle processes for medical devices. The medical device software life cycle processes are derived from IEC 62304:2006, with corresponding safety classes. They have been aligned with the software development life cycle processes of ISO/IEC 12207:2008 and are presented herein in full compliance with ISO/IEC 24774:2010. The content of these three standards provides the foundation of this TR. This TR does not:
- address areas already covered by existing related standards, e.g. the international standards that relate to the four standards used to build this TR (see Bibliography);
- FDA guidance documents; or
- software development tools. This TR describes the process reference model for medical device software development and is limited in scope to the life cycle processes described in IEC 62304:2006. The process names correspond to those of IEC 62304:2006. The mappings provided in Annex B are essential for the alignment between IEC 62304:2006 (which is based on ISO/IEC 12207:1995) and ISO/IEC 12207:2008, developed to address the detailed normative relationship between the two standards. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.
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IEC TR 80002-3
Edition 1.0 2014-06
INTERNATIONAL
STANDARD
Medical device software –
Part 3: Process reference model of medical device software life cycle processes
(IEC 62304)
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.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
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 corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bi bliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and
Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 14
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.
IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a More than 55 000 electrotechnical terminology entries in
variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions
committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries
and withdrawn publications. have been collected from earlier publications of IEC TC 37,
77, 86 and CISPR.
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also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
IEC TR 80002-3
Edition 1.0 2014-06
INTERNATIONAL
STANDARD
Medical device software –
Part 3: Process reference model of medical device software life cycle processes
(IEC 62304)
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
U
ICS 11.040.01 ISBN 978-2-8322-1616-3
– 2 – IEC TR 80002-3:2014 © IEC 2014
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
0.1 Background . 5
0.2 Organization of this technical report . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Medical device software life cycle processes . 7
4.1 Software development process . 7
4.1.1 Software development planning . 7
4.1.2 Software requirements analysis . 8
4.1.3 Software architectural design . 8
4.1.4 Software detailed design . 9
4.1.5 Software unit implementation and verification . 9
4.1.6 Software integration and integration testing . 10
4.1.7 Software system testing . 10
4.1.8 Software release . 11
4.2 Software maintenance . 11
4.2.1 Purpose . 11
4.2.2 Outcomes . 11
4.3 Software risk management . 12
4.3.1 Purpose . 12
4.3.2 Outcomes . 12
4.4 Software configuration management . 13
4.4.1 Purpose . 13
4.4.2 Outcomes . 13
4.5 Software problem resolution. 14
4.5.1 Purpose . 14
4.5.2 Outcomes . 14
Annex A (informative) Development of this technical report . 16
Annex B (informative) Mapping between IEC 62304:2006 and ISO/IEC 12207:2008 . 18
Bibliography . 28
Figure A.1 – Requirements in process elements of IEC 62304:2006 and
ISO/IEC 12207:2008 . 16
Figure A.2 – Development of process outcomes for medical device software
development PRM . 17
Table A.1 – Direct process mappings between IEC 62304:2006 and
ISO/IEC 12207:2008 . 17
Table B.1 – Mapping between process outcomes of the PRM and the requirements of
IEC 62304:2006, including their safety classes, and the requirements of
ISO/IEC 12207:2008 (1 of 9) . 19
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL DEVICE SOFTWARE –
Part 3: Process reference model of medical
device software life cycle processes (IEC 62304)
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) 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.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC TR 80002-3, which is a technical report, 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: Quality management and corresponding general aspects for medical devices.
It is published as a double logo standard.
– 4 – IEC TR 80002-3:2014 © IEC 2014
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/918/DTR 62A/928/RVC
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table. In ISO, the technical report has been approved
by 14 P members out of 16 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2 and in
accordance with ISO/IEC 24774, Systems and software engineering – Life cycle management
– Guidelines for process description.
A list of all parts of the IEC 80002 series, published under the general title Medical device
software, can be found on the IEC website.
The committee has decided that the contents of this 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.
A bilingual version of this publication may be issued at a later date.
INTRODUCTION
0.1 Background
Software is often an integral part of medical device technology. Establishing the safety and
effectiveness of a medical device containing software requires well designed software that
fulfils its purpose without causing any unacceptable risks. Following an internationally
approved set of software development practices provides one way of achieving this.
This technical report (TR) provides a framework of life cycle processes supporting the safe
design and maintenance of medical device software called the process reference model
(PRM). The process descriptions in this PRM are fully compliant with the requirements of
ISO/IEC 24774:2010, Systems and software engineering – Life cycle management –
Guidelines for process description.
This TR presents the PRM for medical device software devel
...
IEC TR 80002-3
Edition 1.0 2014-06
INTERNATIONAL
STANDARD
Medical device software –
Part 3: Process reference model of medical device software life cycle processes
(IEC 62304)
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.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
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 corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bi bliographical information on IEC International Standards, electrical terms containing more than 30 000 terms and
Technical Specifications, Technical Reports and other definitions in English and French, with equivalent terms in 14
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.
IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a More than 55 000 electrotechnical terminology entries in
variety of criteria (reference number, text, technical English and French extracted from the Terms and Definitions
committee,…). It also gives information on projects, replaced clause of IEC publications issued since 2002. Some entries
and withdrawn publications. have been collected from earlier publications of IEC TC 37,
77, 86 and CISPR.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Customer Service Centre - webstore.iec.ch/csc
details all new publications released. Available online and If you wish to give us your feedback on this publication or
also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
IEC TR 80002-3
Edition 1.0 2014-06
INTERNATIONAL
STANDARD
Medical device software –
Part 3: Process reference model of medical device software life cycle processes
(IEC 62304)
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
U
ICS 11.040.01 ISBN 978-2-8322-1616-3
– 2 – IEC TR 80002-3:2014 © IEC 2014
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
0.1 Background . 5
0.2 Organization of this technical report . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Medical device software life cycle processes . 7
4.1 Software development process . 7
4.1.1 Software development planning . 7
4.1.2 Software requirements analysis . 8
4.1.3 Software architectural design . 8
4.1.4 Software detailed design . 9
4.1.5 Software unit implementation and verification . 9
4.1.6 Software integration and integration testing . 10
4.1.7 Software system testing . 10
4.1.8 Software release . 11
4.2 Software maintenance . 11
4.2.1 Purpose . 11
4.2.2 Outcomes . 11
4.3 Software risk management . 12
4.3.1 Purpose . 12
4.3.2 Outcomes . 12
4.4 Software configuration management . 13
4.4.1 Purpose . 13
4.4.2 Outcomes . 13
4.5 Software problem resolution. 14
4.5.1 Purpose . 14
4.5.2 Outcomes . 14
Annex A (informative) Development of this technical report . 16
Annex B (informative) Mapping between IEC 62304:2006 and ISO/IEC 12207:2008 . 18
Bibliography . 28
Figure A.1 – Requirements in process elements of IEC 62304:2006 and
ISO/IEC 12207:2008 . 16
Figure A.2 – Development of process outcomes for medical device software
development PRM . 17
Table A.1 – Direct process mappings between IEC 62304:2006 and
ISO/IEC 12207:2008 . 17
Table B.1 – Mapping between process outcomes of the PRM and the requirements of
IEC 62304:2006, including their safety classes, and the requirements of
ISO/IEC 12207:2008 (1 of 9) . 19
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL DEVICE SOFTWARE –
Part 3: Process reference model of medical
device software life cycle processes (IEC 62304)
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) 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.
The main task of IEC technical committees is to prepare International Standards. However, a
technical committee may propose the publication of a technical report when it has collected
data of a different kind from that which is normally published as an International Standard, for
example "state of the art".
IEC TR 80002-3, which is a technical report, 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: Quality management and corresponding general aspects for medical devices.
It is published as a double logo standard.
– 4 – IEC TR 80002-3:2014 © IEC 2014
The text of this technical report is based on the following documents:
Enquiry draft Report on voting
62A/918/DTR 62A/928/RVC
Full information on the voting for the approval of this technical report can be found in the
report on voting indicated in the above table. In ISO, the technical report has been approved
by 14 P members out of 16 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2 and in
accordance with ISO/IEC 24774, Systems and software engineering – Life cycle management
– Guidelines for process description.
A list of all parts of the IEC 80002 series, published under the general title Medical device
software, can be found on the IEC website.
The committee has decided that the contents of this 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.
A bilingual version of this publication may be issued at a later date.
INTRODUCTION
0.1 Background
Software is often an integral part of medical device technology. Establishing the safety and
effectiveness of a medical device containing software requires well designed software that
fulfils its purpose without causing any unacceptable risks. Following an internationally
approved set of software development practices provides one way of achieving this.
This technical report (TR) provides a framework of life cycle processes supporting the safe
design and maintenance of medical device software called the process reference model
(PRM). The process descriptions in this PRM are fully compliant with the requirements of
ISO/IEC 24774:2010, Systems and software engineering – Life cycle management –
Guidelines for process description.
This TR presents the PRM for medical device software development as a result of integrating
requirements from IEC 62304:2006 and from the international standard of software life-cycle
processes ISO/IEC 12207:2008.
This TR is aimed a
...
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