Name: 04/30089749 DC : DRAFT DEC 2004
Brand: BSI

BS EN 62304 - MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES

Superseded date

11-30-2006

Published date

11-23-2012

Publisher

British Standards Institution

BS EN 62304

Committee	CH/62/1
DocumentType	Draft
PublisherName	British Standards Institution
Status	Superseded
SupersededBy	BS EN 62304 : 2006

IEEE 610.12-1990	IEEE Standard Glossary of Software Engineering Terminology
ISO/IEC 9126-1:2001	Software engineering Product quality Part 1: Quality model
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO/IEC Guide 51:2014	Safety aspects Guidelines for their inclusion in standards
ISO/IEC 12207:2008	Systems and software engineering Software life cycle processes
ISO 9001:2015	Quality management systems — Requirements
ISO 9000:2015	Quality management systems — Fundamentals and vocabulary
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO/IEC 90003:2014	Software engineering Guidelines for the application of ISO 9001:2008 to computer software
IEC 60601-1-4:1996+AMD1:1999 CSV	Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems

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