15/30246774 DC : 0

Superseded

View Superseded by

BS EN 82304-1 - HEALTH SOFTWARE - PART 1: GENERAL REQUIREMENTS FOR PRODUCT SAFETY

Available format(s)

Hardcopy , PDF

Superseded date

03-31-2017

Language(s)

English

Publisher

British Standards Institution

FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 HEALTH SOFTWARE PRODUCT requirements
5 HEALTH SOFTWARE - Software life cycle processes
6 HEALTH SOFTWARE PRODUCT VALIDATION
7 HEALTH SOFTWARE PRODUCT identification and
ACCOMPANYING DOCUMENTS
8 Post-market activities for the HEALTH SOFTWARE PRODUCT
Annex A (informative) - Rationale
Bibliography
Index

BS EN 82304-1.

Committee	CH/62/1
DocumentType	Draft
Pages	29
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS IEC 82304-1 : 2016

IEC 80001-1:2010	Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
IEC 60601-1:2005+AMD1:2012 CSV	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO/IEC 14764:2006	Software Engineering Software Life Cycle Processes Maintenance
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
IEC TR 80001-2-2:2012	Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
IEC 62304:2006+AMD1:2015 CSV	Medical device software - Software life cycle processes
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
IEC 61907:2009	Communication network dependability engineering
ISO/TR 17791:2013	Health informatics Guidance on standards for enabling safety in health software
ISO 14971:2007	Medical devices Application of risk management to medical devices