IEC 82304-1:2016

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

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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

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
HEALTH SOFTWARE –
Part 1: General requirements for product safety

FOREWORD
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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 equi
...