IEC 62304:2006/AMD1:2015

Amendment 1 - Medical device software - Software life cycle processes

Amendement 1 - Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel

General Information

• Status: Published
• Publication Date: 25-Jun-2015
• 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-Jul-2015
• Completion Date: 26-Jun-2015

Relations

• Amends: IEC 62304:2006 - Medical device software - Software life cycle processes
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 62304
Edition 1.0 2015-06
INTERNATIONAL
STANDARD
AMENDMENT 1
Medical device software – Software life cycle processes

IEC 62304:2006-05/AMD1:2015-06(en)

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.: [phone]
3, rue de Varembé Fax: [phone]
CH-1211 Geneva 20 [e-mail]
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
bibliographical 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 15
documents. Available for PC, Mac OS, Android Tablets and additional languages. Also known as the International
iPad. Electrotechnical Vocabulary (IEV) online.

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The advanced search enables to find IEC publications by a More than 60 000 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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IEC 62304
Edition 1.0 2015-06
INTERNATIONAL
STANDARD
AMENDMENT 1
Medical device software – Software life cycle processes

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040 ISBN 978-2-8322-2720-6

– 2 – IEC 62304:2006/AMD1:2015
© IEC 2015
FOREWORD
This amendment 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.
This publication is published as a double logo standard.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/1007/FDIS 62A/1014/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table. In ISO, the standard has been approved by 30 P-
members out of 30 having cast a vote.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website 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 TO THE AMENDMENT
The first edition of IEC 62304 was published in 2006. This amendment is intended to add
requirements to deal with LEGACY SOFTWARE, where the software design is prior to the
existence of the current version, to assist manufacturers who must show compliance to the
standard to meet European Directives. Software safety classification changes needed for this
amendment include clarification of requirements and updating of the software safety
classification to include a risk-based approach. Work is continuing in parallel to develop the
second edition of IEC 62304.
FOREWORD
Add the following note at the end of the Foreword:
NOTE The attention of National Committees is drawn to the fact that equipment MANUFACTURERS and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

© IEC 2015
INTRODUCTION
Replace, in the second paragraph, the existing third sentence with the following:
Each life cycle PROCESS consists of a set of ACTIVITIES, with most ACTIVITIES consisting of a
set of TASKS.
Replace, in the first sentence of the fourth paragraph, the phrase "contributing factor to a
HAZARD" with " contributing factor to a HAZARDOUS SITUATION".
Replace, in the second sentence of the fourth paragraph, the term, "HAZARDS" with
"HAZARDOUS SITUATIONS".
Add, after the existing sixth paragraph, the following new paragraph:
Amendment 1 updates the standard to add requirements to deal with LEGACY SOFTWARE, where
the software design is prior to the existence of the current version, to assist manufacturers
who must show compliance to the standard to meet European Directives. Software safety
classification changes include clarification of requirements and updating of the software
safety classification to include a risk-based approach.
1 Scope
1.2 * Field of application
Replace the entire existing text of this subclause with the following:
This standard 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.
NOTE 1 This standard can be used in the development and maintenance of software that is itself a medical
device. However, additional development activities are needed at the system level before this type of software can
be placed into service. These system activities are not covered by this standard, but can be found in IEC 82304-
1 [22].
This standard describes PROCESSES that are intended to be applied to software which
executes on a processor or which is executed by other software (for example an interpreter)
which executes on a processor.
This standard applies regardless of the persistent storage device(s) used to store the
software (for example: hard disk, optical disk, permanent or flash memory).
This standard applies regardless of the method of delivery of the software (for example:
transmission by network or email, optical disk, flash memory or EEPROM). The method of
software delivery itself is not considered MEDICAL DEVICE SOFTWARE.
This standard does not cover validation and final release of the MEDICAL DEVICE, even when
the MEDICAL DEVICE consists entirely of software.
NOTE 2 If a medical device incorporates embedded software intended to be executed on a processor, the
requirements of this standard apply to the software, including the requirements concerning software of unknown
provenance (see 8.1.2).
___________
In preparation.
– 4 – IEC 62304:2006/AMD1:2015
© IEC 2015
NOTE 3 Validation and other development activities are needed at the system level before the software and
medical device can be placed into service. These system activities are not covered by this standard, but can be
found in related product standards (e.g., IEC 60601-1, IEC 82304-1, etc.).

1.4 Compliance
Delete, in the second paragraph, the instruction “See Annex D.”
Add, after existing Note 4, the following new note:
NOTE 5 For compliance of LEGACY SOFTWARE see 4.4.
3 * Terms and definitions
3.2
ANOMALY
Replace, in the definition, "SOFTWARE PRODUCTS" with "MEDICAL DEVICE SOFTWARE".
Replace the existing source reference with the following note:
NOTE Based on IEEE 1044:1993, definition 3.1.
3.4
CHANGE REQUEST
Replace "SOFTWARE PRODUCT" with "MEDICAL DEVICE SOFTWARE".
3.5
CONFIGURATION ITEM
Replace, in the note, "ISO/IEC 12207:1995, definition 3.6" with "ISO/IEC 12207:2008, 4.7".
3.7
EVALUATION
Replace the existing source reference with "[ISO/IEC 12207:2008, 4.12]".
3.8
HARM
Replace the existing source reference with "[ISO 14971:2007, 2.2]".
3.9
HAZARD
Replace the existing source reference with "[ISO 14971:2007, 2.3]".
3.10
MANUFACTURER
Add the following new notes:
NOTE 1 Attention is drawn to the fact that the provisions of national or regional regulations can apply to the
definition of manufacturer.
NOTE 2 For a definition of labelling, see ISO 13485:2003, definition 3.6.
Replace the existing source reference with "[ISO 14971:2007, 2.8]".

© IEC 2015
3.11
MEDICAL DEVICE
Add the following new note:
NOTE 3 In conjunction with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 the term “medical device”
assumes the same meaning as ME EQUIPMENT or ME SYSTEM (which are defined terms of IEC 60601-1).
3.12
MEDICAL DEVICE SOFTWARE
Replace the existing definition with the following:
SOFTWARE SYSTEM that has been developed for the purpose of being incorporated into the
MEDICAL DEVICE being developed or that is intended for use as a MEDICAL DEVICE
NOTE This includes a MEDICAL DEVICE software product, which then is a MEDICAL DEVICE in its own right.
3.13
PROBLEM REPORT
Replace, in the definition and in Notes 1 and 2, "SOFTWARE PRODUCT" with "MEDICAL DEVICE
SOFTWARE" (4 times).
3.16
RISK
Replace the existing source reference with "[ISO 14971:2007, 2.16]".
3.17
RISK ANALYSIS
Replace the existing source reference with "[ISO 14971:2007, 2.17]".
3.18
RISK CONTROL
Replace the existing source reference with "[ISO 14971:2007, 2.19]".
3.19
RISK MANAGEMENT
Replace the existing source reference with "[ISO 14971:2007, 2.22, modified – The phrase
"and monitoring" has been removed]".
3.20
RISK MANAGEMENT FILE
Replace the existing source reference with "[ISO 14971:2007, 2.23]".
3.21
SAFETY
Replace the existing source reference with "[ISO 14971:2007, 2.24]".
3.22
SECURITY
Replace the existing definition with the following:
protection of information and data so that unauthorized persons or systems cannot read or
modify them an authorized persons or systems are not denied access to them.
NOTE Based on ISO/IEC 12207:2008, 4.39.

– 6 – IEC 62304:2006/AMD1:2015
© IEC 2015
3.23
SERIOUS INJURY
Delete, in the first line of the definition, the words "directly or indirectly".
3.24
SOFTWARE DEVELOPMENT LIFE CYCLE MODEL
Delete, in the second line of the definition, the phrase "for manufacturing".
Replace, in the first dashed item, the words "a SOFTWARE PRODUCT" with "MEDICAL DEVICE
SOFTWARE".
3.25
SOFTWARE ITEM
Replace the existing definition with the following:
any identifiable part of a computer program, i.e., source code, object code, control code,
control data, or a collection of these items
NOTE 1 Three terms identify the software decomposition. The top level is the SOFTWARE SYSTEM. The lowest
level that is not further decomposed is the SOFTWARE UNIT. All levels of composition, including the top and bottom
levels, can be called SOFTWARE ITEMS. A SOFTWARE SYSTEM, then, is composed of one or more SOFTWARE ITEMS,
and each SOFTWARE ITEM is composed of one or more SOFTWARE UNITS or decomposable SOFTWARE ITEMS. The
responsibility is left to the MANUFACTURER to provide the granularity of the SOFTWARE ITEMS and SOFTWARE UNITS.
NOTE 2 Based on ISO/IEC 90003:2004, 3.14 and ISO/IEC 12207:2008, 4.41.
3.26
SOFTWARE PRODUCT
Delete the existing term and definition and add “Not used”.
3.28
SOFTWARE UNIT
Replace the existing note by the following:
NOTE The granularity of SOFTWARE UNITS is defined by the MANUFACTURER (see B.3).
3.29
SOUP
software of unknown provenance (acronym)
Replace, in the third line of the definition, “software previously developed” with ‘SOFTWARE
ITEM previously developed”
Add the following new note:
NOTE A MEDICAL DEVICE SOFTWARE SYSTEM in itself cannot be claimed to be SOUP.
3.30
SYSTEM
Replace the existing source reference with the following note:
NOTE Based on ISO/IEC 12207:2008, 4.48.
3.32
TRACEABILITY
Add the following new note:
© IEC 2015
NOTE Requirements, architecture, risk control measures, etc. are examples of deliverables of the development
PROCESS.
3.34
VERSION
Replace, in the existing text of Note1, the words "a SOFTWARE PRODUCT" with "MEDICAL DEVICE
SOFTWARE".
Replace the existing text of Note 2 with the following
NOTE 2 Based on ISO/IEC 12207:2008, 4.56.
Add the following new definitions:
3.35
HAZARDOUS SITUATION
circumstance in which people, property or the environment are exposed to one or more
HAZARD(S)
[SOURCE: ISO 14971:2007, 2.4]
3.36
LEGACY SOFTWARE
MEDICAL DEVICE SOFTWARE which was legally placed on the market and is still marketed today
but for which there is insufficient objective evidence that it was developed in compliance with
the current version of this standard
3.37
RELEASE
particular VERSION of a CONFIGURATION ITEM that is made available for a specific purpose
NOTE B
...

IEC 62304
Edition 1.0 2015-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical device software – Software life cycle processes

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

IEC 62304:2006-05/AMD1:2015-06(en-fr)

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
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IEC Central Office Tel.: [phone]
3, rue de Varembé Fax: [phone]
CH-1211 Geneva 20 [e-mail]
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
bibliographical information on IEC International Standards, electrical terms containing 20 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 16 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. 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 65 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and

CISPR.
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IEC 62304
Edition 1.0 2015-06
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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 11.040 ISBN 978-2-8322-4638-2

– 2 – IEC 62304:2006/AMD1:2015
© IEC 2015
FOREWORD
This amendment 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.
This publication is published as a double logo standard.
This bilingual version (2017-09) corresponds to the monolingual English version, published in
2015-06.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/1007/FDIS 62A/1014/RVD
Full information on the voting for the approval of this amendment can be found in the report
on voting indicated in the above table. In ISO, the standard has been approved by 30 P-
members out of 30 having cast a vote.
The French version of this amendment has not been voted upon.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC website 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.
_____________
INTRODUCTION TO THE AMENDMENT 1
The first edition of IEC 62304 was published in 2006. This amendment is intended to add
requirements to deal with LEGACY SOFTWARE, where the software design is prior to the
existence of the current version, to assist manufacturers who must show compliance to the
standard to meet European Directives. Software safety classification changes needed for this
amendment include clarification of requirements and updating of the software safety
classification to include a risk-based approach. Work is continuing in parallel to develop the
second edition of IEC 62304.
FOREWORD
Add the following note at the end of the Foreword:
NOTE The attention of National Committees is drawn to the fact that equipment MANUFACTURERS and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or
ISO publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.
INTRODUCTION
Replace, in the second paragraph, the existing third sentence with the following:

© IEC 2015
Each life cycle PROCESS consists of a set of ACTIVITIES, with most ACTIVITIES consisting of a set
of TASKS.
Replace, in the first sentence of the fourth paragraph, the phrase "contributing factor to a
HAZARD" with " contributing factor to a HAZARDOUS SITUATION".
Replace, in the second sentence of the fourth paragraph, the term, "HAZARDS" with
"HAZARDOUS SITUATIONS".
Add, after the existing sixth paragraph, the following new paragraph:
Amendment 1 updates the standard to add requirements to deal with LEGACY SOFTWARE, where
the software design is prior to the existence of the current version, to assist manufacturers
who must show compliance to the standard to meet European Directives. Software safety
classification changes include clarification of requirements and updating of the software safety
classification to include a risk-based approach.
1 Scope
1.2 * Field of application
Replace the entire existing text of this subclause with the following:
This standard 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.
NOTE 1 This standard can be used in the development and maintenance of software that is itself a medical
device. However, additional development activities are needed at the system level before this type of software can
be placed into service. These system activities are not covered by this standard, but can be found in IEC 82304-1
[22].
This standard describes PROCESSES that are intended to be applied to software which
executes on a processor or which is executed by other software (for example an interpreter)
which executes on a processor.
This standard applies regardless of the persistent storage device(s) used to store the
software (for example: hard disk, optical disk, permanent or flash memory).
This standard applies regardless of the method of delivery of the software (for example:
transmission by network or email, optical disk, flash memory or EEPROM). The method of
software delivery itself is not considered MEDICAL DEVICE SOFTWARE.
This standard does not cover validation and final release of the MEDICAL DEVICE, even when
the MEDICAL DEVICE consists entirely of software.
NOTE 2 If a medical device incorporates embedded software intended to be executed on a processor, the
requirements of this standard apply to the software, including the requirements concerning software of unknown
provenance (see 8.1.2).
NOTE 3 Validation and other development activities are needed at the system level before the software and
medical device can be placed into service. These system activities are not covered by this standard, but can be
found in related product standards (e.g., IEC 60601-1, IEC 82304-1, etc.).

1.4 Compliance
Delete, in the second paragraph, the instruction “See Annex D.”
Add, after existing Note 4, the following new note:
NOTE 5 For compliance of LEGACY SOFTWARE see 4.4.
___________
In preparation.
– 4 – IEC 62304:2006/AMD1:2015
© IEC 2015
3 * Terms and definitions
3.2
ANOMALY
Replace, in the definition, "SOFTWARE PRODUCTS" with "MEDICAL DEVICE SOFTWARE".
Replace the existing source reference with the following note:
NOTE Based on IEEE 1044:1993, definition 3.1.
3.4
CHANGE REQUEST
Replace "SOFTWARE PRODUCT" with "MEDICAL DEVICE SOFTWARE".
3.5
CONFIGURATION ITEM
Replace, in the note, "ISO/IEC 12207:1995, definition 3.6" with "ISO/IEC 12207:2008, 4.7".
3.7
EVALUATION
Replace the existing source reference with "[ISO/IEC 12207:2008, 4.12]".
3.8
HARM
Replace the existing source reference with "[ISO 14971:2007, 2.2]".
3.9
HAZARD
Replace the existing source reference with "[ISO 14971:2007, 2.3]".
3.10
MANUFACTURER
Add the following new notes:
NOTE 1 Attention is drawn to the fact that the provisions of national or regional regulations can apply to the
definition of manufacturer.
NOTE 2 For a definition of labelling, see ISO 13485:2003, definition 3.6.
Replace the existing source reference with "[ISO 14971:2007, 2.8]".
3.11
MEDICAL DEVICE
Add the following new note:
NOTE 3 In conjunction with IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 the term “medical device”
assumes the same meaning as ME EQUIPMENT or ME SYSTEM (which are defined terms of IEC 60601-1).
3.12
MEDICAL DEVICE SOFTWARE
Replace the existing definition with the following:
SOFTWARE SYSTEM that has been developed for the purpose of being incorporated into the
MEDICAL DEVICE being developed or that is intended for use as a MEDICAL DEVICE
NOTE This includes a MEDICAL DEVICE software product, which then is a MEDICAL DEVICE in its own right.
3.13
PROBLEM REPORT
SOFTWARE PRODUCT" with "MEDICAL DEVICE
Replace, in the definition and in Notes 1 and 2, "
SOFTWARE" (4 times).
© IEC 2015
3.16
RISK
Replace the existing source reference with "[ISO 14971:2007, 2.16]".
3.17
RISK ANALYSIS
Replace the existing source reference with "[ISO 14971:2007, 2.17]".
3.18
RISK CONTROL
Replace the existing source reference with "[ISO 14971:2007, 2.19]".
3.19
RISK MANAGEMENT
Replace the existing source reference with "[ISO 14971:2007, 2.22, modified – The phrase
"and monitoring" has been removed]".
3.20
RISK MANAGEMENT FILE
Replace the existing source reference with "[ISO 14971:2007, 2.23]".
3.21
SAFETY
Replace the existing source reference with "[ISO 14971:2007, 2.24]".
3.22
SECURITY
Replace the existing definition with the following:
protection of information and data so that un
...