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I.S. EN 62304:2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
Available format(s)

Hardcopy , PDF

Superseded date

07-16-2020

Language(s)

English

Published date

01-01-2006

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

National Foreword
European foreword
FOREWORD
INTRODUCTION
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Software development PROCESS
6 Software maintenance PROCESS
7 Software RISK MANAGEMENT PROCESS
8 Software configuration management PROCESS
9 Software problem resolution PROCESS
Annex A (informative) - Rationale for the requirements of
        this standard
Annex B (informative) - Guidance on the provisions of this
        standard
Annex C (informative) - Relationship to other standards
Annex D (informative) - Implementation
Annex ZA (normative) - Normative references to international
         publications with their corresponding European
         publications
Annex ZZ (informative) - Coverage of Essential Requirements
         of EC Directives
Bibliography
Index of defined terms

This standard defines the life cycle requirements for MEDICAL DEVICE SOFTWARE.

Committee
ISO/IEC JTC 1
DevelopmentNote
For CENELEC adoptions of IEC publications, please check www.iec.ch to be sure that you have any corrigenda that may apply. (01/2017)
DocumentType
Standard
ISBN
2-8318-8637-6
Pages
176
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

Standards Relationship
NBN EN 62304 : 2007 Identical
EN 62304:2006/A1:2015 Identical
DIN EN 62304 : 2016 Identical
IEC 62304:2006+AMD1:2015 CSV Identical
BS EN 62304 : 2006 Identical
UNE-EN 62304:2007 Identical
NF EN 62304 : 2006 AMD 1 2018 Identical

ISO/IEC 15504-5:2012 Information technology Process assessment Part 5: An exemplar software life cycle process assessment model
IEEE 610.12-1990 IEEE Standard Glossary of Software Engineering Terminology
ISO/IEC 25010:2011 Systems and software engineering — Systems and software Quality Requirements and Evaluation (SQuaRE) — System and software quality models
IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
ISO/IEC 33001:2015 Information technology Process assessment Concepts and terminology
IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
ISO/IEC 14764:2006 Software Engineering Software Life Cycle Processes Maintenance
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
IEC 61508-3:2010 Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508)
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/IEC 90003:2014 Software engineering Guidelines for the application of ISO 9001:2008 to computer software
IEC 61010-1:2010+AMD1:2016 CSV Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
ISO/IEC 33004:2015 Information technology Process assessment Requirements for process reference, process assessment and maturity models

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