• NEN EN 50103 : 1995

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR THE ACTIVE (INCLUDING ACTIVE IMPLANTABLE) MEDICAL DEVICE INDUSTRY

    Available format(s): 

    Superseded date:  01-07-2005

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Netherlands 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 Netherlands Standards
    Status Superseded
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