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  • BS EN 46002:1997

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Specification for application of EN ISO 9002 to the manufacture of medical devices

    Available format(s):  Hardcopy, PDF

    Superseded date:  23-07-2013

    Language(s):  English

    Published date:  15-02-1997

    Publisher:  British Standards Institution

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

    Cooperating organizations
    National foreword
    Foreword
    0. Introduction
    1. Scope and field of application
    2. Normative references
    3. Definitions
    4. Quality system requirements
    4.1 Management responsibility
    4.2 Quality system
    4.3 Contract review
    4.4 Document control
    4.5 Purchasing
    4.6 Purchaser supplied product
    4.7 Product identification and traceability
    4.8 Process control
    4.9 Inspection and testing
    4.10 Inspection, measuring and test equipment
    4.11 Inspection and test status
    4.12 Control of nonconforming product
    4.13 Corrective action
    4.14 Handling, storage, packaging and delivery
    4.15 Quality records
    4.16 Internal quality audits
    4.17 Training
    4.18 Statistical techniques
    Annex A (informative) - Bibliography
    National annex NA (informative) Committees responsible
    National annex NB (informative) Cross-references

    Abstract - (Show below) - (Hide below)

    Specifies additional requirements for quality systems used in manufacture of medical devices.

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

    Committee CH/210/1
    Development Note DRAFT FOR COMMENT 91/58124 DC
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    BS EN 724:1995 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for non-active medical devices
    BS EN 1283:1996 Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits
    BS EN 50103:1996 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
    BS EN 554:1994 Sterilization of medical devices. Validation and routine control of sterilization by moist heat
    BS EN 928:1996 Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices
    BS EN 550:1994 Sterilization of medical devices. Validation and routine control of ethylene oxide sterilization

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

    EN ISO 9002:1994/AC:1997 QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION
    EN ISO 8402 : 1995 QUALITY MANAGEMENT AND QUALITY ASSURANCE - VOCABULARY
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