IEC 82304-1:2016
(Main)Health software - Part 1: General requirements for product safety
Health software - Part 1: General requirements for product safety
IEC 82304-1:2016 applies to the safety and security of health software products designed to operate on general computing platforms and intended to be placed on the market without dedicated hardware, and its primary focus is on the requirements for manufacturers. It covers the entire lifecycle including design, development, validation, installation, maintenance, and disposal of health software products.
Logiciels de santé - Partie 1: Exigences générales pour la sécurité des produits
L'IEC 82304-1:2016 s'applique à la sécurité et à la sureté des produits logiciels de santé conçus pour fonctionner sur des plates-formes informatiques générales et destinés à être commercialisés sans matériel dédié. Ce document se concentre principalement sur les exigences destinées aux fabricants. Il couvre le cycle de vie complet y compris la conception, le développement, la validation, l'installation, la maintenance et l'élimination des produits logiciels de santé.
General Information
Standards Content (Sample)
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
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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
...
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