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    I.S. EN ISO 6717:2021

    Current The latest, up-to-date edition.

    In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  26-09-2021

    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)

    Foreword
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Materials
    5 Filling capacity/draw volume
    6 Graduation lines
    7 Design
    8 Construction
    9 Sterility and special microbiological states
    10 Additives
    11 Marking and labelling
    Annex A (normative) Tests for filling capacity and/or graduation lines for non-evacuated specimen container
    Annex B (normative) Draw volume test for evacuated containers
    Annex C (normative) Test for leakage from the closure of a container
    Annex D (normative) Test for the robustness of a container that is intended for centrifugation
    Bibliography

    Abstract - (Show below) - (Hide below)

    This document specifies requirements and test methods for specialized single-use evacuated and nonevacuated containers, intended by their manufacturers, for the primary containment and preservation of specimens, other than blood specimens, derived from the human body, for the purposes of in vitro diagnostic examination. It is not intended to cover specimen containers for forensic investigations.

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

    Committee ISO/TC 76
    Document Type Standard
    Product Note The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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