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  • DIN EN ISO 21536:2014-07

    Current The latest, up-to-date edition.

    NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - SPECIFIC REQUIREMENTS FOR KNEE-JOINT REPLACEMENT IMPLANTS (ISO 21536:2007 + AMD.1:2014)

    Available format(s):  Hardcopy, PDF

    Language(s):  German

    Published date:  01-07-2014

    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 EN ISO 21536:2009
    Foreword to EN ISO 21536:2009/A1:2014
    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 range of
            relative angular motion of components of fully
            constrained total knee joint replacement implants
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EU Directive 93/42/EEC on medical devices

    Abstract - (Show below) - (Hide below)

    Defines requirements for knee joint replacement implants.

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

    Committee TC 150
    Development Note Supersedes DIN EN 12564. (12/2007)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Current
    Supersedes

    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
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    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
    DIN EN ISO 21534:2009-08 NON-ACTIVE SURGICAL IMPLANTS - JOINT REPLACEMENT IMPLANTS - PARTICULAR REQUIREMENTS
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