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04/30089749 DC : DRAFT DEC 2004

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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

Published date

23-11-2012

Superseded date

30-11-2006

Superseded by

BS EN 62304 : 2006

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BS EN 62304

Committee
CH/62/1
DocumentType
Draft
PublisherName
British Standards Institution
Status
Superseded
SupersededBy

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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