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  • DIN EN ISO 21535 E : 2017

    Current The latest, up-to-date edition.

    NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR HIP-JOINT REPLACEMENT IMPLANTS (ISO 21535:2007 + AMD 1:2016)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    National Annex NA (informative) - Bibliography
    Foreword to DIN EN ISO 21535:2017
    European foreword to Amendment A1 of DIN EN ISO 21535
    Introduction
    1 Scope
    2 Normative references
    3 Terms and 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 (informative) - Evaluation of relative angular
            motion of components
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 93/42/EEC
    Annex ZB (informative) - Correlations between undated
             normative references and dated EN and ISO standards

    Abstract - (Show below) - (Hide below)

    Gives specific requirements for hip joint replacement implants.

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

    Development Note Supersedes DIN EN 12563 E. (01/2008)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current

    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 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
    DIN EN ISO 21534 E : 2009 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
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