BS EN 62304 : 2006
Current
The latest, up-to-date edition.
MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES
Hardcopy , PDF
English
01-01-2006
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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
Specifies the life cycle requirements for MEDICAL DEVICE SOFTWARE. The set of PROCESSES, ACTIVITIES, and TASKS described in this standard establishes a common framework for MEDICAL DEVICE SOFTWARE life cycle PROCESSES.
| Committee |
CH/62/1
|
| DevelopmentNote |
Supersedes 04/30089749 DC (11/2006) 2006 Edition Re-Issued in November 2015 & incorporates AMD 1 2015. 2006 Edition along with its corrigendum is still active & will be withdrawn on 31/07/2018. Supersedes 14/30287753 DC. (11/2015)
|
| DocumentType |
Standard
|
| Pages |
88
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| 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 |
| I.S. EN 62304:2006 | Identical |
| UNE-EN 62304:2007 | Identical |
| NF EN 62304 : 2006 AMD 1 2018 | Identical |
| BS PAS 277(2015) : 2015 | HEALTH AND WELLNESS APPS - QUALITY CRITERIA ACROSS THE LIFE CYCLE - CODE OF PRACTICE |
| EN 61508-3:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements |
| 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 |
| EN 60601-1-6:2010/A1:2015 | MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
| 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 |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| ISO/IEC 12207:2008 | Systems and software engineering — Software life cycle processes |
| ISO 9001:2015 | Quality management systems — Requirements |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| EN 61010-1:2010 | Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| EN 60601-1-4:1996/A1:1999 | MEDICAL ELECTRICAL EQUIPMENT - GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
| 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 |
| EN ISO 9000:2015 | Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
| ISO/IEC 33004:2015 | Information technology Process assessment Requirements for process reference, process assessment and maturity models |
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