EN 82304-1:2017

SLOVENSKI STANDARD
01-oktober-2017
Programska oprema v zdravstvu - 1. del: Splošne zahteve za varnost proizvodov
(IEC 82304-1:2016)
Health Software - Part 1: General requirements for product safety (IEC 82304-1:2016)
Ta slovenski standard je istoveten z: EN 82304-1:2017
ICS:
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 82304-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2017
ICS 35.240.80
English Version
Health Software - Part 1: General requirements for product
safety
(IEC 82304-1:2016)
Logiciels de santé - Partie 1: Exigences générales pour la Gesundheitssoftware - Teil 1: Allgemeine Anforderungen für
sécurité des produits die Produktsicherheit
(IEC 82304-1:2016) (IEC 82304-1:2016)
This European Standard was approved by CENELEC on 2016-12-01. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard 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 European Standard 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, Serbia, 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
© 2017 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 82304-1:2017 E
European foreword
The text of document 62A/1140/FDIS, future edition 1 of IEC 82304-1, prepared by IEC/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 EN 82304-1:2017.
The following dates are fixed:
• latest date by which the document has (dop) 2018-03-01
to be implemented at national level by
publication of an identical national
standard or by endorsement
(dow) 2020-09-01
• 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 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.
Endorsement notice
The text of the International Standard IEC 82304-1:2016 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:
IEC 60601 (series) NOTE Harmonized as EN 60601 (series).
IEC 60601-1:2005 NOTE Harmonized as EN 60601-1:2006.
IEC 61907:2009 NOTE Harmonized as EN 61907:2010.
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015.
IEC 80001-1:2010 NOTE Harmonized as EN 80001-1:2011.
ISO 9000:2015 NOTE Harmonized as EN ISO 9000:2015.
ISO 13485:2015 NOTE Harmonized as EN ISO 13485:2016.
ISO 14971:2007 NOTE Harmonized as EN ISO 14971:2012.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are

indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod), the relevant

EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is available here:
www.cenelec.eu.
Publication Year Title EN/HD Year

IEC 62304 2006 Medical device software - Software life- EN 62304 2006
cycle processes
- -  + corrigendum Nov. 2008
+ A1 2015  + A1 2015
IEC 82304-1
Edition 1.0 2016-10
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Health software –
Part 1: General requirements for product safety

Logiciels de santé –
Partie 1: Exigences générales pour la sécurité des produits

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 35.240.80 ISBN 978-2-8322-3733-5

– 2 – IEC 82304-1:2016 © IEC 2016
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
1 Scope . 6
1.1 Purpose . 6
1.2 Field of application . 6
1.3 Compliance . 6
2 Normative references . 6
3 Terms and definitions . 7
4 * HEALTH SOFTWARE PRODUCT requirements . 10
4.1 General requirements and initial RISK ASSESSMENT . 10
4.2 HEALTH SOFTWARE PRODUCT use requirements . 11
4.3 VERIFICATION of HEALTH SOFTWARE PRODUCT use requirements . 11
4.4 Updating HEALTH SOFTWARE PRODUCT use requirements . 12
4.5 System requirements . 12
4.6 VERIFICATION of system requirements . 12
4.7 Updating HEALTH SOFTWARE PRODUCT system requirements . 12
5 * HEALTH SOFTWARE – Software life cycle processes . 13
6 * HEALTH SOFTWARE PRODUCT VALIDATION . 13
6.1 VALIDATION plan . 13
6.2 Performing VALIDATION . 13
6.3 VALIDATION report . 14
7 HEALTH SOFTWARE PRODUCT identification and ACCOMPANYING DOCUMENTS . 14
7.1 * Identification . 14
7.2 ACCOMPANYING DOCUMENTS . 14
7.2.1 General . 14
7.2.2 Instructions for use . 15
7.2.3 Technical description . 17
8 Post-market activities for the HEALTH SOFTWARE PRODUCT . 18
8.1 General . 18
8.2 SOFTWARE MAINTENANCE . 18
8.3 Re-VALIDATION . 19
8.4 Post-market communication on the HEALTH SOFTWARE PRODUCT . 19
8.5 Decommissioning and disposal of the HEALTH SOFTWARE PRODUCT . 19
Annex A (informative) Rationale . 20
A.1 General . 20
A.2 Requirements for HEALTH SOFTWARE PRODUCTS . 21
A.3 Rationale for particular clauses and subclauses . 22
Bibliography . 26

Figure A.1 – HEALTH SOFTWARE application domains and scope of related standards . 22
Figure A.2 – IEC 82304-1: HEALTH SOFTWARE PRODUCT processes . 23

Table A.1 – Examples of software (SW) in or not in the scope of this document . 21

IEC 82304-1:2016 © IEC 2016 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
HEALTH SOFTWARE –
Part 1: General requirements for product safety

FOREWORD
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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.
International Standard IEC 82304-1 has been prepared by 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 215: Health
informatics.
It is published as a double logo standard.
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