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  • BS EN 928:1996

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    Guidance on the application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in vitro diagnostic medical devices

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  28-09-2007

    Language(s):  English

    Published date:  15-06-1996

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 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 nonconforming 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
    Annex A (informative) Bibliography

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

    Committee CH/210/1
    Development Note Supersedes 92/58310 DC. (09/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Withdrawn
    Supersedes

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

    EN 550 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
    BS 5750-2:1987 Quality systems Specification for production and installation
    EN 724 : 1994 GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES
    BS EN 46002:1997 Specification for application of EN ISO 9002 to the manufacture of medical devices
    BS 5750-0.2(1987) : 1987 QUALITY SYSTEMS - PRINCIPAL CONCEPTS AND APPLICATIONS - GUIDE TO QUALITY MANAGEMENT AND QUALITY SYSTEM ELEMENTS
    EN 552:1994/A2:2000 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION
    BS 5750-1:1987 Quality systems Specification for design/development, production, installation and servicing
    BS EN 46001:1997 Specification for application of EN ISO 9001 to the manufacture of medical devices
    EN 554 : 1994 STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT
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