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    ISO 23908:2011

    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

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, French, Russian

    Published date:  27-05-2011

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 23908:2011 gives 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. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection.

    It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.

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

    Development Note Supersedes ISO/DIS 23908. (05/2011)
    Document Type Standard
    Product Note THIS STANDARD ALSO REFERS-ISO 2859 (all parts),ISO 3951 (all parts),NATICK/TR-92/011
    Publisher International Organization for Standardization
    Status Current

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN EN ISO 3826-4 E : 2015 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
    13/30273308 DC : 0 BS EN ISO 3826-4 - PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES
    15/30328959 DC : 0 BS ISO 16142-2 - MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    DIN EN ISO 3826-4:2015-12 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
    16/30282706 DC : 0 BS ISO 11608-6 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 6: ON-BODY DELIVERY SYSTEMS
    ISO 11040-8:2016 Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes
    UNE-EN ISO 11608-5:2013 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
    DIN EN ISO 11608-5:2013-01 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
    DIN ISO 11040-4 E : 2017 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    BS ISO 11040-4:2015 Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling
    BS EN ISO 7864:2016 Sterile hypodermic needles for single use. Requirements and test methods
    I.S. EN ISO 8537:2016 STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016)
    I.S. EN ISO 7864:2016 STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014)
    16/30339096 DC : 0 BS EN ISO 7886-3 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION
    BS EN ISO 11608-5:2012 Needle-based injection systems for medical use. Requirements and test methods Automated functions
    ISO 16142-1:2016 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    PD ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters
    13/30273499 DC : 0 BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING
    BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    UNI EN ISO 11608-5 : 2013 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS
    EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
    15/30304642 DC : 0 BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES
    15/30289037 DC : 0 BS EN ISO 7886-1 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE
    14/30296389 DC : 0 BS EN ISO 7864 - STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS
    I.S. EN ISO 7886-1:1998 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE (ISO 7886-1:2017)
    ISO/TR 19244:2014 Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
    ISO 11040-4:2015 Prefilled syringes Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
    UNE-EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
    BS EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    UNE-EN ISO 7864:2017 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN ISO 11608-5:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)
    BS EN ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features
    DIN ISO 11040-4:2007-10 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)
    I.S. EN ISO 3826-4:2015 PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
    I.S. EN ISO 11608-5:2012 NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012)
    ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    ISO 11608-5:2012 Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions
    ISO 3826-4:2015 Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features
    DIN ISO 11040-4:2017-07 PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015)

    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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