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  • EN ISO 1135-3:2017

    Current The latest, up-to-date edition.

    Transfusion equipment for medical use - Part 3: Blood-taking sets for single use (ISO 1135-3:2016)

    Available format(s): 

    Language(s): 

    Published date:  22-02-2017

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Foreword
    1 Scope
    2 Normative references
    3 General requirements
    4 Materials
    5 Physical requirements
    6 Chemical requirements
    7 Biological requirements
    8 Labelling
    9 Packaging
    10 Disposal
    Annex A (normative) - Physical tests
    Annex B (normative) - Chemical tests
    Annex C (normative) - Biological tests
    Bibliography
    Annex ZA (informative) - Relationship between this
             European standard and the essential requirements
             of Directive 93/42/EEC [OJ L 169] aimed to be
             covered

    Abstract - (Show below) - (Hide below)

    ISO 1135-3:2016 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only.ISO 1135-3:2016 also aims to providea) specifications relating to the quality and performance of materials used in transfusion equipment, and b) a unified presentation of terms for such equipment.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-3:2016.

    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 3826-2:2008 Plastics collapsible containers for human blood and blood components — Part 2: Graphical symbols for use on labels and instruction leaflets
    ISO 10993-4:2017 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood
    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 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    DIN 13097-4:2009-08 HYPODERMIC NEEDLES - PART 4: POINT GEOMETRY, REQUIREMENTS AND TESTING
    ISO 1773:1997 Laboratory glassware Narrow-necked boiling flasks
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 291:2008 Plastics Standard atmospheres for conditioning and testing
    IEC 80416-1:2008 Basic principles for graphical symbols for use on equipment - Part 1: Creation of graphical symbols for registration
    ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    DIN 13097-5:2008-11 HYPODERMIC NEEDLES - PART 5: SOCKETS, HUBS AND CONNECTIONS - REQUIREMENTS AND TESTING
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    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 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment 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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