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  • BS EN 62304 : 2006

    Current The latest, up-to-date edition.

    MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2006

    Publisher:  British Standards Institution

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CH/62/1
    Development Note 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Re-Issued in November 2015 & incorporates AMD 1 2015. 2006 Edition along with its corrigendum is still active & will be withdrawn on 31/07/2018.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)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    BS PAS 277(2015) : 2015 HEALTH AND WELLNESS APPS - QUALITY CRITERIA ACROSS THE LIFE CYCLE - CODE OF PRACTICE

    Standards Referencing This Book - (Show below) - (Hide below)

    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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