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  • ISO 21535:2007

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 hip-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    Superseded date:  05-07-2023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 21535:2007 provides specific requirements for hip 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 21535. (10/2007)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Superseded
    Superseded By
    Supersedes

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

    04/300654 DC : DRAFT JAN 2004 BS EN ISO 14630 - NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    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
    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
    ISO 7206-1:2008 Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions
    I.S. EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
    ASTM F 3018 : 2017 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
    UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    BS ISO 7206-1:2008 Implants for surgery. Partial and total hip joint prostheses Classification 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)
    ASTM F 2582 : 2014 : REDLINE Standard Test Method for Impingement of Acetabular Prostheses
    ASTM F 2091 : 2015 : REDLINE Standard Specification for Acetabular Prostheses
    ISO 14630:2012 Non-active surgical implants General requirements

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

    ISO 7206-10:2003 Implants for surgery Partial and total hip-joint prostheses Part 10: Determination of resistance to static load of modular femoral heads
    ISO 14242-1:2014 Implants for surgery Wear of total hip-joint prostheses Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test
    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 21534:2007 Non-active surgical implants Joint replacement implants Particular requirements
    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 14242-3:2009 Implants for surgery Wear of total hip-joint prostheses Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test
    ISO 14242-2:2016 Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement
    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 14630:2012 Non-active surgical implants General requirements
    ASTM F 3047M : 2015 Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
    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
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