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  • UNI EN ISO 23908 : 2013

    Current The latest, up-to-date edition.

    SHARPS INJURY PROTECTION - REQUIREMENTS AND TEST METHODS - SHARPS PROTECTION FEATURES FOR SINGLE-USE HYPODERMIC NEEDLES, INTRODUCERS FOR CATHETERS AND NEEDLES USED FOR BLOOD SAMPLING

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    Published date:  03-04-2013

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Test methods
    6 Information supplied by the manufacturer
    Annex A (informative) - Guidance on simulated user studies
    Annex B (informative) - Method for testing access to the
            sharp in safe mode
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements
             of EU Directive 93/42/EEC on Medical Devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Provides requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling.

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

    Committee CT 44
    Document Type Test Method
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Current
    Supersedes

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

    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 16269-6:2014 Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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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