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  • BS EN ISO 14602:2011

    Current The latest, up-to-date edition.

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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  31-10-2011

    Publisher:  British Standards Institution

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    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.

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    Committee CH/150/5
    Development Note Supersedes 95/561932 DC (08/2004) To be read in conjunction with BS EN ISO 14630. (02/2010) Supersedes 09/30198885 DC. (05/2010)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

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

    2007/47/EC : 2007 COR 1 2015 DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE)
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO/TR 14283:2004 Implants for surgery Fundamental principles
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