第1页 / 共176页
第2页 / 共176页
第3页 / 共176页
第4页 / 共176页
第5页 / 共176页
第6页 / 共176页
第7页 / 共176页
第8页 / 共176页
IEC 62304-2015 Medicaldevicesoftware–Softwarelifecycleprocesses.....pdf
Redline version
CONTENTS
FOREWORD
INTRODUCTION
INTRODUCTION to Amendment 1
1 Scope
1.1 *€Purpose
1.2 *€Field of application
1.3 Relationship to other standards
1.4 Compliance
2 *€Normative references
3 *€Terms and definitions
4 *€General requirements
4.1 *€Quality management system
4.2 *€Risk management
4.3 *€Software safety classification
4.4 *€Legacy software
5 Software development process
5.1 *€Software development planning
5.2 *€Software requirements analysis
5.3 *€Software architectural design
5.4 *€Software detailed design
5.5 * Software unit implementation
5.6 *€Software integration and integration testing
5.7 *€Software system testing
5.8 *€Software release for utilization at a system level
6 Software maintenance process
6.1 *€Establish software maintenance plan
6.2 *€Problem and modification analysis
6.3 *€Modification implementation
7 *€Software risk management process
7.1 *€Analysis of software contributing to hazardous situations
7.2 Risk control measures
7.3 Verification of risk control measures
7.4 Risk management of software changes
8 *€Software configuration management process
8.1 *€Configuration identification
8.2 *€Change control
8.3 *€Configuration status accounting
9 *€Software problem resolution process
9.1 Prepare problem reports
9.2 Investigate the problem
9.3 Advise relevant parties
9.4 Use change control process
9.5 Maintain records
9.6 Analyse problems for trends
9.7 Verify software problem resolution
9.8 Test documentation contents
Annex A (informative) Rationale for the requirements of this standard
Annex B (informative) Guidance on the provisions of this standard
Annex C (informative) Relationship to other standards
Annex D (informative) Implementation
Bibliography
Index of defined terms
Figures
Figure 1 – Overview of software development processes and activities
Figure 2 – Overview of software maintenance processes and activities
Figure 3 – Assigning software safety classification
Figure B.2 – Pictorial representation of the relationship of hazard, sequence of events, hazardous situation, and harm – from ISO 14971:2007 Annex E
Figure B.1 – Example of partitioning of software items
Figure C.1 – Relationship of key medical device standards to IEC 62304
Figure C.2 – Software as part of the V-model
Figure C.3 – Application of IEC 62304 with IEC 61010-1
Tables
Table A.1 – Summary of requirements by software safety class
Table B.1 – Development (model) strategies as defined in ISO/IEC 12207
Table C.1 – Relationship to ISO 13485:2003
Table C.2 – Relationship to ISO 14971:2007
Table C.3 – Relationship to IEC 60601-1
Table C.5 – Relationship to ISO/IEC 12207:2008
Table D.1 – Checklist for small companies without a certified QMS
Final version
CONTENTS
FOREWORD
INTRODUCTION
INTRODUCTION to Amendment 1
1 Scope
1.1 *€Purpose
1.2 *€Field of application
1.3 Relationship to other standards
1.4 Compliance
2 *€Normative references
3 *€Terms and definitions
4 *€General requirements
4.1 *€Quality management system
4.2 *€Risk management
4.3 *€Software safety classification
4.4 *€Legacy software
5 Software development process
5.1 *€Software development planning
5.2 *€Software requirements analysis
5.3 *€Software architectural design
5.4 *€Software detailed design
5.5 *€Software unit implementation
5.6 *€Software integration and integration testing
5.7 *€Software system testing
5.8 *€Software release for utilization at a system level
6 Software maintenance process
6.1 *€Establish software maintenance plan
6.2 *€Problem and modification analysis
6.3 *€Modification implementation
7 *€Software risk management process
7.1 *€Analysis of software contributing to hazardous situations
7.2 Risk control measures
7.3 Verification of risk control measures
7.4 Risk management of software changes
8 *€Software configuration management process
8.1 *€Configuration identification
8.2 *€Change control
8.3 *€Configuration status accounting
9 *€Software problem resolution process
9.1 Prepare problem reports
9.2 Investigate the problem
9.3 Advise relevant parties
9.4 Use change control process
9.5 Maintain records
9.6 Analyse problems for trends
9.7 Verify software problem resolution
9.8 Test documentation contents
Annex A (informative) Rationale for the requirements of this standard
Annex B (informative) Guidance on the provisions of this standard
Annex C (informative) Relationship to other standards
Annex D (informative) Implementation
Bibliography
Index of defined terms
Figures
Figure 1 – Overview of software development processes and activities
Figure 2 – Overview of software maintenance processes and activities
Figure 3 – Assigning software safety classification
Figure B.1 – Example of partitioning of software items
Figure B.2 – Pictorial representation of the relationship of hazard, sequence of events, hazardous situation, and harm – from ISO 14971:2007 Annex E
Figure C.1 – Relationship of key medical device standards to IEC 62304
Figure C.2 – Software as part of the V-model
Figure C.3 – Application of IEC 62304 with IEC 61010-1
Tables
Table A.1 – Summary of requirements by software safety class
Table B.1 – Development (model) strategies as defined in ISO/IEC 12207
Table C.1 – Relationship to ISO 13485:2003
Table C.2 – Relationship to ISO 14971:2007
Table C.3 – Relationship to IEC 60601-1
Table C.5 – Relationship to ISO/IEC 12207:2008
Table D.1 – Checklist for small companies without a certified QMS
CONSOLIDATED
VERSION
IEC 62304
Edition 1.1 2015-06
Medical device software – Software life cycle processes
)
n
e
(
V
S
C
6
0
-
5
1
0
2
:
1
D
M
A
+
5
0
-
6
0
0
2
:
4
0
3
2
6
C
E
I
colourinsideCopyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=Hong Kong Polytechnic University/9976803100 Not for Resale, 02/27/2016 18:17:02 MSTNo reproduction or networking permitted without license from IHS--`,````````````,,,,``,```````,-`-`,,`,,`,`,,`---
THIS PUBLICATION IS COPYRIGHT PROTECTED
Copyright © 2015 IEC, Geneva, Switzerland
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
3, rue de Varembé
CH-1211 Geneva 20
Switzerland
Tel.: +41 22 919 02 11
Fax: +41 22 919 03 00
info@iec.ch
www.iec.ch
for consulting
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
The stand-alone application
the entire
bibliographical information on IEC International Standards,
Technical Specifications, Technical Reports and other
documents. Available for PC, Mac OS, Android Tablets and
iPad.
IEC publications search - www.iec.ch/searchpub
The advanced search enables to find IEC publications by a
variety of criteria
technical
committee,…). It also gives information on projects, replaced
and withdrawn publications.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published
details all new publications released. Available online and
also once a month by email.
Electropedia - www.electropedia.org
The world's leading online dictionary of electronic and
electrical terms containing more than 30 000 terms and
definitions in English and French, with equivalent terms in 15
additional
International
languages. Also known as
Electrotechnical Vocabulary (IEV) online.
IEC Glossary - std.iec.ch/glossary
More than 60 000 electrotechnical terminology entries in
English and French extracted from the Terms and Definitions
clause of IEC publications issued since 2002. Some entries
have been collected from earlier publications of IEC TC 37,
77, 86 and CISPR.
IEC Customer Service Centre - webstore.iec.ch/csc
If you wish to give us your feedback on this publication or
need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
(reference number,
text,
the
Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=Hong Kong Polytechnic University/9976803100 Not for Resale, 02/27/2016 18:17:02 MSTNo reproduction or networking permitted without license from IHS--`,````````````,,,,``,```````,-`-`,,`,,`,`,,`---
IEC 62304
Edition 1.1 2015-06
CONSOLIDATED
VERSION
Medical device software – Software life cycle processes
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040
ISBN 978-2-8322-2765-7
Warning! Make sure that you obtained this publication from an authorized distributor.
colourinsideCopyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=Hong Kong Polytechnic University/9976803100 Not for Resale, 02/27/2016 18:17:02 MSTNo reproduction or networking permitted without license from IHS--`,````````````,,,,``,```````,-`-`,,`,,`,`,,`---
Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=Hong Kong Polytechnic University/9976803100 Not for Resale, 02/27/2016 18:17:02 MSTNo reproduction or networking permitted without license from IHS--`,````````````,,,,``,```````,-`-`,,`,,`,`,,`---
IEC 62304
Edition 1.1 2015-06
REDLINE VERSION
Medical device software – Software life cycle processes
)
n
e
(
V
S
C
6
0
-
5
1
0
2
:
1
D
M
A
+
5
0
-
6
0
0
2
:
4
0
3
2
6
C
E
I
colourinsideCopyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=Hong Kong Polytechnic University/9976803100 Not for Resale, 02/27/2016 18:17:02 MSTNo reproduction or networking permitted without license from IHS--`,````````````,,,,``,```````,-`-`,,`,,`,`,,`---
– 2 –
CONTENTS
IEC 62304:2006
+AMD1:2015 CSV IEC 2015
2
3
4
5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
FOREWORD ........................................................................................................................ 4
INTRODUCTION .................................................................................................................. 6
INTRODUCTION to Amendment 1 ........................................................................................ 8
1 Scope ............................................................................................................................ 9
* Purpose .............................................................................................................. 9
1.1
1.2
* Field of application .............................................................................................. 9
1.3 Relationship to other standards ............................................................................. 9
1.4 Compliance ........................................................................................................... 9
* Normative references ................................................................................................. 10
* Terms and definitions ................................................................................................. 10
* General requirements ................................................................................................ 15
* Quality management system ............................................................................. 15
4.1
* RISK MANAGEMENT .............................................................................................. 16
4.2
* Software safety classification ............................................................................ 16
4.3
4.4
* LEGACY SOFTWARE ............................................................................................. 18
5 Software development PROCESS .................................................................................... 19
* Software development planning ......................................................................... 19
* Software requirements analysis ......................................................................... 21
* Software ARCHITECTURAL design......................................................................... 23
* Software detailed design ................................................................................... 24
* SOFTWARE UNIT implementation and verification ................................................. 25
* Software integration and integration testing ....................................................... 25
* SOFTWARE SYSTEM testing .................................................................................. 27
* Software release ............................................................................................... 28
6 Software maintenance PROCESS .................................................................................... 29
* Establish software maintenance plan ................................................................. 29
6.1
* Problem and modification analysis ..................................................................... 30
6.2
* Modification implementation .............................................................................. 31
6.3
* 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
* Software configuration management PROCESS ............................................................ 33
8.1
* Configuration identification ................................................................................ 33
* Change control ................................................................................................. 33
8.2
8.3
* Configuration status accounting ........................................................................ 34
* 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 ....................................................................... 35
7
8
9
Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=Hong Kong Polytechnic University/9976803100 Not for Resale, 02/27/2016 18:17:02 MSTNo reproduction or networking permitted without license from IHS--`,````````````,,,,``,```````,-`-`,,`,,`,`,,`---
IEC 62304:2006
+AMD1:2015 CSV IEC 2015
– 3 –
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 60601-4 ...............................................................................
Table C.5 – Relationship to ISO/IEC 12207 ......................................................................... 74
Table D.1 – Checklist for small companies without a certified QMS ..................................... 85
Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=Hong Kong Polytechnic University/9976803100 Not for Resale, 02/27/2016 18:17:02 MSTNo reproduction or networking permitted without license from IHS--`,````````````,,,,``,```````,-`-`,,`,,`,`,,`---
– 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) 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.
DISCLAIMER
This Consolidated version is not an official IEC Standard and has been prepared for
user convenience. Only the current versions of the standard and its amendment(s) are
to be considered the official documents.
This Consolidated version of IEC 62304 bears the edition number 1.1. It consists of the
first edition (2006-05) [documents 62A/523/FDIS and 62A/528/RVD] and its amendment 1
(2015-06) [documents 62A/1007/FDIS and 62A/1014/RVD]. The technical content is
identical to the base edition and its amendment.
In this Redline version, a vertical line in the margin shows where the technical content is
modified by amendment 1. Additions and deletions are displayed in red, with deletions
being struck through. A separate Final version with all changes accepted is available in
this publication.
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
Copyright International Electrotechnical Commission Provided by IHS under license with IECLicensee=Hong Kong Polytechnic University/9976803100 Not for Resale, 02/27/2016 18:17:02 MSTNo reproduction or networking permitted without license from IHS--`,````````````,,,,``,```````,-`-`,,`,,`,`,,`---
相关推荐
2023年江西萍乡中考道德与法治真题及答案.doc
2012年重庆南川中考生物真题及答案.doc
2013年江西师范大学地理学综合及文艺理论基础考研真题.doc
2020年四川甘孜小升初语文真题及答案I卷.doc
2020年注册岩土工程师专业基础考试真题及答案.doc
2023-2024学年福建省厦门市九年级上学期数学月考试题及答案.doc
2021-2022学年辽宁省沈阳市大东区九年级上学期语文期末试题及答案.doc
2022-2023学年北京东城区初三第一学期物理期末试卷及答案.doc
2018上半年江西教师资格初中地理学科知识与教学能力真题及答案.doc
2012年河北国家公务员申论考试真题及答案-省级.doc
2020-2021学年江苏省扬州市江都区邵樊片九年级上学期数学第一次质量检测试题及答案.doc
2022下半年黑龙江教师资格证中学综合素质真题及答案.doc
