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  • EN ISO 6710 : 2017

    Current The latest, up-to-date edition.
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    SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO 6710:2017)

    Available format(s): 

    Language(s): 

    Published date:  06-09-2017

    Publisher:  Comite Europeen de Normalisation

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

    European foreword
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Materials
    5 Draw volume
    6 Design
    7 Construction
    8 Sterility and special microbiological states
    9 Additives
    10 Marking and labelling
    11 Container identification
    Annex A (normative) - Draw volume test for
            non-evacuated containers
    Annex B (normative) - Draw volume test for
            evacuated containers
    Annex C (normative) - Test for leakage of container
    Annex D (normative) - Test for robustness of the container
    Annex E (normative) - Concentrations of additives
            and volume of liquid additives
    Annex F (informative) - Recommended colour
            codes for identifying additives and accessories
    Bibliography
    Annex ZA (informative) - Relationship between this
             European standard and the essential
             requirements of Directive 98/79/EC
             [OJ L 331] aimed to be covered

    Abstract - (Show below) - (Hide below)

    Defines requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers.

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

    Committee TC 140
    Development Note Supersedes EN 14820. (09/2017)
    Document Type Test Method
    Publisher Comite Europeen de Normalisation
    Status Current

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

    ISO 11137-1:2006 Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    EN 556-1:2001/AC:2006 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED "STERILE" - PART 1: REQUIREMENTS FOR TERMINALLY STERILIZED MEDICAL DEVICES
    EN 556-2 : 2015 STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR MEDICAL DEVICES TO BE DESIGNATED 'STERILE' - PART 2: REQUIREMENTS FOR ASEPTICALLY PROCESSED MEDICAL DEVICES
    ISO/TS 17665-2:2009 Sterilization of health care products Moist heat Part 2: Guidance on the application of ISO 17665-1
    ISO 11137-2:2013 Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 14820 : 2004 SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION
    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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