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  • UNE-EN ISO 8536-11:2015

    Current The latest, up-to-date edition.

    Infusion equipment for medical use - Part 11: Infusion filters for single use with pressure infusion equipment (ISO 8536-11:2015)

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  11-11-2015

    Publisher:  Asociacion Espanola de Normalizacion

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

    1 Scope
    2 Normative references
    3 Designation
    4 Design
    5 Materials
    6 Physical requirements
       6.1 Transparency
       6.2 Particulate contamination
       6.3 Tensile strength
       6.4 Leakage
       6.5 Adapters with female and/or male conical fittings
       6.6 Protective caps
    7 Chemical requirements
    8 Biological requirements
       8.1 Sterility
       8.2 Pyrogens
       8.3 Haemolysis
    9 Packaging
    10 Labelling
       10.1 Unit container
       10.2 Shelf or multi-unit container
    Annex A (normative) Physical tests
    Annex B (normative) Chemical tests
    Annex C (normative) Biological tests
    Bibliography

    Abstract - (Show below) - (Hide below)

    Pertains to sterilized infusion filters for single use up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8.

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

    Committee CTN 111
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current
    Supersedes

    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 8536-8:2015 Infusion equipment for medical use - Part 8: Infusion sets for single use with pressure infusion apparatus (ISO 8536-8:2015)
    EN ISO 10993-4:2017 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
    ISO 11137-2:2013 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
    ISO 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
    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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