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  • BS ISO 7198 : 1998

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    CARDIOVASCULAR IMPLANTS - TUBULAR VASCULAR PROSTHESES

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-03-2017

    Language(s):  English

    Published date:  01-01-1998

    Publisher:  British Standards Institution

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

    1 Scope
    2 Normative references
    3 Terms and definitions
    4 General requirements
    5 Requirements for finished prosthesis
    6 Requirements for in vivo preclinical and clinical
        evaluation
    7 Sampling
    8 Test methods for vascular prostheses
    9 In vivo preclinical and clinical test methods for
        vascular prostheses
    10 Information to be recorded and disclosed by the
        manufacturer on request

    Abstract - (Show below) - (Hide below)

    Defines requirements regarding testing, packaging, labelling and terminology for sterile tubular vascular prostheses for replacement, bypass or for forming shunts between segments of the vascular system in humans.

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

    Committee CH/150/2
    Development Note Supersedes 96/561667 DC. (07/2005)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 2960:1974 Textiles Determination of bursting strength and bursting distension Diaphragm method
    ISO 5084:1996 Textiles Determination of thickness of textiles and textile products
    ISO 2076:2013 Textiles Man-made fibres Generic names
    ISO 2859-2:1985 Sampling procedures for inspection by attributes Part 2: Sampling plans indexed by limiting quality (LQ) for isolated lot inspection
    ISO 5081:1977 Textiles Woven fabrics Determination of breaking strength and elongation (Strip method)
    ASTM D 76 : 1999 Standard Specification for Tensile Testing Machines for Textiles
    ISO 472:2013 Plastics Vocabulary
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
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