• S.R. CR 14060:2000

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    MEDICAL DEVICE TRACEABILITY

    Available format(s):  Hardcopy, PDF

    Superseded date:  20-12-2014

    Language(s):  English

    Published date:  01-01-2000

    Publisher:  National Standards Authority of Ireland

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

    Foreword
    Introduction
    1 Scope
    2 Definition
    3 The Distribution Chain
    4 Traceability/review of the concept
    Bibliography

    Abstract - (Show below) - (Hide below)

    Presents recommendations for procedures that should be followed to establish, as far as possible, a traceability route for medical devices which have been placed on the market.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    ISO 13488:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9002
    EN 46001 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    EN 46002 : 1996 QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002
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