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  • EN ISO 8536-14:2018

    Current The latest, up-to-date edition.

    Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact (ISO 8536-14:2016)

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    Published date:  07-02-2018

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Annex ZA (informative) - Relationship between this European
             standard and the essential requirements
             of Directive 93/42/EEC [OJ L 169] aimed to
             be covered
    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Design
    5 Materials
    6 Physical requirements
    Annex A (normative) - Physical tests
    Bibliography

    Abstract - (Show below) - (Hide below)

    ISO 8536-14:2016 specifies requirements for non-sterile clamps and flow regulators used as a subcomponent to control the flow of intravenous solutions and/or blood components through sterilized infusion and blood transfusion sets and blood bag assemblies without fluid contact.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 8536-14:2016.

    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 8536-4:2010 Infusion equipment for medical use Part 4: Infusion sets for single use, gravity feed
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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