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  • 13/30284770 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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 8536-9 - INFUSION EQUIPMENT FOR MEDICAL USE - PART 9: FLUID LINES FOR USE WITH PRESSURE INFUSION EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-06-2015

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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

    Foreword
    1 Scope
    2 Normative references
    3 Designation
    4 Materials
    5 Physical requirements
    6 Chemical requirements
    7 Biological requirements
    8 Packaging
    9 Labelling
    Annex A (normative) - Physical tests
    Annex B (normative) - Chemical tests
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements
             of EC Directive 93/42/EEC on medical devices

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

    Comment Closes On
    Committee CH/212
    Document Type Draft
    Publisher British Standards Institution
    Status Superseded
    Superseded By

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

    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
    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 8536-11:2015 Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
    ISO 8536-10:2015 Infusion equipment for medical use Part 10: Accessories for fluid lines for single use with pressure infusion equipment
    ISO 11134:1994 Sterilization of health care products — Requirements for validation and routine control — Industrial moist heat sterilization
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 11137:1995 Sterilization of health care products Requirements for validation and routine control Radiation sterilization
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
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