• DIN EN 46001:1996-09

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001

    Available format(s):  Hardcopy, PDF

    Superseded date:  01-02-2001

    Language(s):  English

    Published date:  01-01-1996

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    Foreword
    0 Introduction
    1 Scope
    2 Normative references
    3 Definitions
    4 Quality system requirements
       4.1 Management responsibility
       4.2 Quality system
       4.3 Contract review
       4.4 Design control
       4.5 Document and data control
       4.6 Purchasing
       4.7 Control of customer-supplied product
       4.8 Product identification and traceability
       4.9 Process control
       4.10 Inspection and testing
       4.11 Control of inspection, measuring and test equipment
       4.12 Inspection and test status
       4.13 Control of nonconforming product
       4.14 Corrective and preventive action
       4.15 Handling, storage, packaging, preservation and delivery
       4.16 Control of quality records
       4.17 Internal quality audits
       4.18 Training
       4.19 Servicing
       4.20 Statistical techniques
    Annex A (informative) - Bibliography

    Abstract - (Show below) - (Hide below)

    Specifies the quality system requirements for the design/development, production, and where relevant, installation and servicing of medical devices.

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

    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By

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

    DIN 58946-6:2002-04 STERILIZATION - STEAM STERILIZERS - PART 6: OPERATING OF LARGE STERILIZERS IN HEALTH CARE FACILITIES

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

    DIN EN ISO 9001:2015-11 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015)
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