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  • BS EN 12564:1999

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Non-active surgical implants. Joint replacement implants. Specific requirements for knee joint replacement implants

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-09-2008

    Language(s):  English

    Published date:  15-04-1999

    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 Intended performance
    5 Design attributes
    6 Materials
    7 Design evaluation
    8 Manufacture
    9 Sterilization
    10 Packaging
    11 Information to be supplied by the manufacturer
    Annex A (normative) Evaluation of range of relative angular motion
            of components of fully constrained total knee joint
            replacement implants
    Annex B (normative) Bibliography
    Annex ZA (informative) Clauses of this European Standard addressing
             essential requirements or other provisions of EU Directives

    Abstract - (Show below) - (Hide below)

    Defines specific requirements for knee joint replacement implants. Conforming to safety, gives requirements for intended performance, manufacture, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer and methods of test.

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

    Committee CH/150/4
    Development Note Supersedes 96/563169 DC. (08/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    EN 12010 : 1998 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO 7207-1:2007 Implants for surgery Components for partial and total knee joint prostheses Part 1: Classification, definitions and designation of dimensions
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
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