• I.S. EN ISO 7886-3:2009

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  30-11-2020

    Language(s):  English

    Published date:  01-01-2009

    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
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Nomenclature
    5 Cleanliness
    6 Limits for acidity or alkalinity
    7 Limits for extractable metals
    8 Lubricant
    9 Tolerance on nominal capacity
    10 Graduated scale
    11 Barrel
    12 Piston/plunger assembly
    13 Needle
    14 Performance
    15 Packaging
    16 Labelling
    Annex A (normative) Method for preparation of extracts
    Annex B (informative) Test method for forces required
             to operate plunger
    Annex C (normative) Test method for testing auto-disable
             feature
    Annex ZA (informative) Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC on medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines the properties and performance of sterile single-use hypodermic syringes with or without needle, made of plastic materials and stainless steel and intended for the aspiration of vaccines or for the injection of vaccines immediately after filling.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Withdrawn
    Superseded By
    Supersedes

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

    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
    ISO 780:2015 Packaging Distribution packaging Graphical symbols for handling and storage of packages
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
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