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  • ISO 21536:2007

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Superseded date:  05-07-2023

    Language(s): 

    Published date:  26-09-2007

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 21536:2007 provides specific requirements for knee joint replacement implants. With regard to safety, this International Standard specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging, information supplied by the manufacturer and methods of test.

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

    Committee ISO/TC 150/SC 4
    Development Note Supersedes ISO/DIS 21536. (10/2007)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 19233-1:2017 Implants for surgery — Orthopaedic joint prosthesis — Part 1: Procedure for producing parametric 3D bone models from CT data of the knee
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    BS EN ISO 14630:2012 Non-active surgical implants. General requirements
    I.S. EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
    04/300654 DC : DRAFT JAN 2004 BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    BS ISO 7207-1:2007 Implants for surgery. Components for partial and total knee joint prostheses Classification, definitions and designation of dimensions
    UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    16/30300186 DC : 0 BS ISO 19233-1 - IMPLANTS FOR SURGERY - ORTHOPAEDIC JOINT PROSTHESIS - PART 1: PROCEDURE FOR PRODUCING PARAMETRIC 3D BONE MODELS FROM CT DATA OF THE KNEE
    BS ISO 19233-1:2017 Implants for surgery. Orthopaedic joint prosthesis Procedure for producing parametric 3D bone models from CT data of the knee
    ISO 7207-1:2007 Implants for surgery Components for partial and total knee joint prostheses Part 1: Classification, definitions and designation of dimensions
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    UNE-EN ISO 14630:2013 Non-active surgical implants - General requirements (ISO 14630:2012)
    EN ISO 14630:2012 Non-active surgical implants - General requirements (ISO 14630:2012)
    ISO 14630:2012 Non-active surgical implants General requirements

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

    ISO 21534:2007 Non-active surgical implants Joint replacement implants Particular requirements
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO 7207-2:2011 Implants for surgery — Components for partial and total knee joint prostheses — Part 2: Articulating surfaces made of metal, ceramic and plastics materials
    ISO 14879-1:2000 Implants for surgery Total knee-joint prostheses Part 1: Determination of endurance properties of knee tibial trays
    ISO 7207-1:2007 Implants for surgery Components for partial and total knee joint prostheses Part 1: Classification, definitions and designation of dimensions
    ISO 14243-3:2014 Implants for surgery Wear of total knee-joint prostheses Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test
    ISO 14243-1:2009 Implants for surgery Wear of total knee-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test
    ISO 14243-2:2016 Implants for surgery — Wear of total knee-joint prostheses — Part 2: Methods of measurement
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