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  • NEN 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

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    Published date:  12-01-2013

    Publisher:  Netherlands Standards

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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 used 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)

    Document Type Standard
    Publisher Netherlands Standards
    Status Current
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