• NBN EN 50103 : 2000

    Current The latest, up-to-date edition.

    RICHTLINJEN VOOR DE TOEPASSING VAN EN 29001 EN EN 46001 EN VAN EN 29002 EN EN 46002 VOOR DE INDUSTRIE VAN ACTIEVE MEDISCHE PRODUKTEN (MET INBEGRIP VAN ACTIEVE IMPLANTATEN)

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    Published date:  12-01-2013

    Publisher:  Belgian Standards

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

    Foreword
    Introduction
    1. Scope
    2. Normative references
    3. Terminology and definitions
    3.1 Terminology
    3.2 Definitions
    4. Guidance on QUALITY SYSTEM requirements
    4.1 Management responsibility
    4.2 QUALITY SYSTEM
    4.3 Contract review
    4.4 Design control
    4.5 Document control
    4.6 Purchasing
    4.7 PURCHASER supplied PRODUCT
    4.8 PRODUCT identification and traceability
    4.9 Process control
    4.10 INSPECTION AND TESTING
    4.11 INSPECTION, measuring and test equipment
    4.12 INSPECTION and test status
    4.13 Control of non-conforming PRODUCT
    4.14 CORRECTIVE ACTION
    4.15 Handling, storage, packaging and delivery
    4.16 Quality records
    4.17 Internal QUALITY AUDITS
    4.18 Training
    4.19 Servicing
    4.20 Statistical techniques
    Annexes
    A. (informative) Terminology - Index of terms
    B. (informative) Bibliography

    Abstract - (Show below) - (Hide below)

    Contains guidelines for suppliers of active medical devices (including active implantable medical devices) who wish to ensure that they comply with EN 46001.

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    Document Type Standard
    Publisher Belgian Standards
    Status Current
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