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  • ISO 14602:2010

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    Non-active surgical implants — Implants for osteosynthesis — Particular requirements

    Available format(s):  Hardcopy, PDF 1 User, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  French, English, Russian

    Published date:  12-04-2010

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 14602:2010 specifies particular requirements for non-active surgical Implants for osteosynthesis, referred to as implants.

    In addition to ISO 14630, ISO 14602:2010 gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

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

    Development Note To be read in conjunction with ISO 14630. Supersedes ISO/DIS 14602. (04/2010)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    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
    ASTM F 382 : 2017 : REDLINE Standard Specification and Test Method for Metallic Bone Plates
    BS EN ISO 14630:2012 Non-active surgical implants. General requirements
    EN 12011 : 1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    ASTM F 384 : 2017 : REDLINE Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices
    BS ISO 15142-1:2003 Implants for surgery. Metal intramedullary nailing systems Intramedullary nails
    ISO 15142-2:2003 Implants for surgery Metal intramedullary nailing systems Part 2: Locking components
    I.S. EN ISO 14630:2012 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS (ISO 14630:2012)
    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 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
    ISO 15142-1:2003 Implants for surgery Metal intramedullary nailing systems Part 1: Intramedullary nails
    UNI EN ISO 14630 : 2013 NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    BS ISO 15142-2:2003 Implants for surgery. Metal intramedullary nailing systems Locking components
    I.S. EN 12011:1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    ONORM EN ISO 5398-3 : 2007 LEATHER - CHEMICAL DETERMINATION OF CHROMIC OXIDE CONTENT - PART 3: QUANTIFICATION BY ATOMIC ABSORPTION SPECTROMETRY
    DIN EN ISO 14630:2013-03 Non-active surgical implants - General requirements (ISO 14630:2012)
    BS EN 12011:1998 INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS
    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)
    ONORM EN ISO 5398-4 : 2007 LEATHER - CHEMICAL DETERMINATION OF CHROMIC OXIDE CONTENT - PART 4: QUANTIFICATION BY INDUCTIVELY COUPLED PLASMA - OPTICAL EMISSION SPECTROMETER (ICP-OES)
    ISO 14630:2012 Non-active surgical implants General requirements
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