IEC 62304:2006/AMD1:2015

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)

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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• withdrawn,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
...