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  • BS EN ISO 6710:2017

    Current The latest, up-to-date edition.

    Single-use containers for human venous blood specimen collection

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  03-10-2017

    Publisher:  British Standards Institution

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

    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

    Abstract - (Show below) - (Hide below)

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

    Scope - (Show below) - (Hide below)

    This document specifies requirements and test methods for evacuated and non-evacuated single-use venous blood specimen containers.

    It does not specify requirements for blood collection needles, needle holders, blood culture receptacles or “arterial?? blood gas collection devices that can be used for venous blood.

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

    Committee CH/212
    Development Note Supersedes 16/30348158 DC & BS EN 14820. (10/2017)
    Document Type Standard
    Publisher British Standards Institution
    Status Current
    Supersedes

    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 556-2:2015 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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