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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 ISO 13485 - MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES

    Available format(s):  Hardcopy, PDF

    Superseded date:  29-02-2016

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    0 Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Quality management system
    5 Management
    6 Resource management
    7 Product realization
    8 Measurement, analysis and improvement
    Annex A (informative) - Comparison of content of
            ISO 13485:2003 and ISO DIS2 13485:2015
    Annex ZA (informative) - Relationship between this
             European Standard and the Conformity Assessment
             Requirements of EU Directive 90/385/EEC (as amended)
    Annex ZB (informative) - Relationship between this
             European Standard and the Conformity Assessment
             Requirements of EU Directive 93/42/EEC (as amended)
    Annex ZC (informative) - Relationship between this
             European Standard and the Conformity Assessment
             Requirements of EU Directive 98/79/EC (as amended)
    Bibliography

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

    Comment Closes On
    Committee CH/210/1
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 19011:2011 Guidelines for auditing management systems
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO/TS 16775:2014 Packaging for terminally sterilized medical devices Guidance on the application of ISO 11607-1 and ISO 11607-2
    ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
    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 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
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