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  • EN ISO 8536-9:2015

    Current The latest, up-to-date edition.

    Infusion equipment for medical use - Part 9: Fluid lines for single use with pressure infusion equipment (ISO 8536-9:2015)

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    Published date:  17-06-2015

    Publisher:  Comite Europeen de Normalisation

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

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

    Abstract - (Show below) - (Hide below)

    ISO 8536-9:2015 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).The following items are covered by ISO 8536-9:2015:a) syringe pump lines (SPL);b) connecting lines (CL);c) lines with integrated injection cannula (LIC).

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

    Committee CEN/TC 205
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Current

    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 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 8536-8:2015 Infusion equipment for medical use Part 8: Infusion sets for single use with pressure infusion apparatus
    EN ISO 8536-11:2015 Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)
    EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN ISO 8536-10:2015 Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment (ISO 8536-10:2015)
    ISO 8536-11:2015 Infusion equipment for medical use Part 11: Infusion filters for single use with pressure infusion equipment
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    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 7000:2014 Graphical symbols for use on equipment Registered symbols
    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
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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