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  • 14/30281557 DC : 0

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    BS EN ISO 7198 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES

    Available format(s):  Hardcopy, PDF

    Superseded date:  31-03-2017

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    1 Scope
    2 Normative references
    3 Definitions
    4 General requirements
    5 Intended performance
    6 Design attributes
    7 Materials
    8 Design evaluation
    9 Preclinical in vivo evaluation
       test methods for vascular prostheses
    10 Clinical investigation methods for
       vascular prostheses
    11 Manufacturing
    12 Sterility
    13 Packaging and Labeling
    Annex A (Informative) - Test Methods

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

    Comment Closes On
    Committee CH/150/2
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 14160:2011 Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
    ISO 13488:1996 Quality systems — Medical devices — Particular requirements for the application of ISO 9002
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    ISO 14630:2012 Non-active surgical implants General requirements
    ISO 11607:2003 Packaging for terminally sterilized medical devices
    ISO 14155:2011 Clinical investigation of medical devices for human subjects Good clinical practice
    ISO 14971:2007 Medical devices Application of risk management to medical devices
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