EN 62304:2006/A1:2015

Medical device software - Software life-cycle processes

PWI created for possible future // procedures

Medizingeräte-Software - Software-Lebenszyklus-Prozesse

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

Programska oprema za medicinske aparate - Procesi v življenjskem ciklu programske opreme - Dopolnilo A1

General Information

• Status: Published
• Publication Date: 15-Oct-2015
• Withdrawal Date: 30-Jul-2018
• ICS: 11.040 - Medical equipment
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62A - IEC_SC_62A
• Current Stage: 6060 - Document made available - Publishing
• Start Date: 16-Oct-2015
• Completion Date: 16-Oct-2015
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/432 - Standardisation Mandate addressed to CEN and CENELEC within the framework of Directive 2007/47/EC amending Directive 90/385/EEC and Directive 93/42/EEC relating to Medical Devices
• Ref Project: SIST EN 62304:2006/A1:2015 - Medical device software - Software life-cycle processes

Relations

• Amends: EN 62304:2006 - Medical device software - Software life-cycle processes
• Effective Date: 28-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2015
Programska oprema za medicinske aparate - Procesi v življenjskem ciklu
programske opreme - Dopolnilo A1
Medical device software - Software life-cycle processes
Medizingeräte-Software - Software-Lebenszyklus-Prozesse
Logiciels de dispositifs médicaux - Processus du cycle de vie du logiciel
Ta slovenski standard je istoveten z: EN 62304:2006/A1:2015
ICS:
13.020.60 Življenjski ciklusi izdelkov Product life-cycles
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 62304:2006/A1

NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2015
ICS 11.040
English Version
Medical device software - Software life-cycle processes
(IEC 62304:2006/A1:2015)
Logiciels de dispositifs médicaux - Processus du cycle de Medizingeräte-Software - Software-Lebenszyklus-Prozesse
vie du logiciel (IEC 62304:2006/A1:2015)
(IEC 62304:2006/A1:2015)
This amendment A1 modifies the European Standard EN 62304:2006; it was approved by CENELEC on 2015-07-31. CENELEC members
are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the status of a
national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.

European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 62304:2006/A1:2015 E

European Foreword
The text of document 62A/1007/FDIS, future IEC 62304:2006/A1, prepared by SC 62A "Common
aspects of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in
medical practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
The following dates are fixed:
• latest date by which the document has to be (dop) 2016-05-01
implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2018-07-31
• latest date by which the national
standards conflicting with the
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC [and/or CEN] shall not be held responsible for identifying any or all such
patent rights.
This document has been prepared under a mandate given to CENELEC by the European Commission
and the European Free Trade Association, and supports essential requirements of EU Directive.

For the relationship with EU Directive 93/42/EEC, 98/79/EC, 90/385/EEC see informative Annex ZZ,
included in EN 62304:2006/corrigendum Nov. 2008.
Endorsement notice
The text of the International Standard IEC 62304:2006/A1:2015 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
Replace the existing references with the following:

IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006.
IEC 60601-1:2005/AMD1:2012 NOTE Harmonized as EN 60601-1:2006/A1:2013.
IEC 60601-1-4:1996 NOTE Harmonized as EN 60601-1-4:1996.
IEC 60601-1-4:1996/AMD1:1999 NOTE Harmonized as EN 60601-1-4:1996/A1:1999.
IEC 60601-1-6 NOTE Harmonized as EN 60601-1-6.
IEC 61508-3 NOTE Harmonized as EN 61508-3.
IEC 61010-1:2010 NOTE Harmonized as EN 61010-1:2010.
ISO 9000:2005 NOTE Harmonized as EN ISO 9000:2005.
ISO 9001:2008 NOTE Harmonized as EN ISO 9001:2008.
ISO 13485:2003 NOTE Harmonized as EN ISO 13485:2003.
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015.
1)
NOTE Harmonized as EN 82304-1
IEC 82304-1
1) At draft stage.
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 62304:2006/AMD1:2015 – 3 –
© 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 62304:2006/AMD1:2015 – 5 –
© 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 phra
...