• BS EN 12563:1999

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    Non-active surgical implants. Joint replacement implants. Specific requirements for hip joint replacement implants

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-10-2008

    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 relative angular motion
             of components
    Annex B (informative) 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 hip joint replacement implants. In conjunction with safety, given also are requirements for intended performance, materials, design evaluation, design attributes, sterilization, manufacture, 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 96/563168 DC. (08/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 7206-8:1995 Implants for surgery — Partial and total hip joint prostheses — Part 8: Endurance performance of stemmed femoral components with application of torsion
    ISO 7206-4:2010 Implants for surgery Partial and total hip joint prostheses Part 4: Determination of endurance properties and performance of stemmed femoral components
    ISO 7206-9:1994 Implants for surgery Partial and total hip joint prostheses Part 9: Determination of resistance to torque of head fixation of stemmed femoral components
    EN 12010 : 1998 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
    ISO 7206-6:2013 Implants for surgery — Partial and total hip joint prostheses — Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components
    ISO/TR 9326:1989 Implants for surgery Partial and total hip joint prostheses Guidance for laboratory evaluation of change of form of bearing surfaces
    ISO/TR 9325:1989 Implants for surgery Partial and total hip joint prostheses Recommendations for simulators for evaluation of hip joint prostheses
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO 7206-2:2011 Implants for surgery — Partial and total hip joint prostheses — Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
    ISO 7206-1:2008 Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
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