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  • 15/30314236 DC : 0

    NA Status of Standard is Unknown

    BS ISO 15676 - CARDIOVASCULAR IMPLANTS AND ARTIFICIAL ORGANS - REQUIREMENTS FOR SINGLE-USE TUBING PACKS FOR CARDIOPULMONARY BYPASS AND EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirement
    5 Tests and measurements
    6 Information supplied by the manufacturer
    7 Packaging
    Bibliography

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

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

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

    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
    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
    ASTM D 792 : 2013 : REDLINE Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
    ISO 9352:2012 Plastics — Determination of resistance to wear by abrasive wheels
    ISO 34-1:2015 Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces
    ISO 10993-11:2017 Biological evaluation of medical devices — Part 11: Tests for systemic toxicity
    ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
    ISO 1183-1:2012 Plastics Methods for determining the density of non-cellular plastics Part 1: Immersion method, liquid pyknometer method and titration method
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
    ISO 527-1:2012 Plastics Determination of tensile properties Part 1: General principles
    ISO 868:2003 Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore hardness)
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