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    I.S. EN ISO 6710:2017

    Current The latest, up-to-date edition.

    SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO 6710:2017)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  01-01-2017

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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

    National Foreword
    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)

    Development Note Supersedes I.S. EN 14820. (10/2017)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    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 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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