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  • EN ISO 7886-3:2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Sterile hypodermic syringes for single use - Part 3: Auto-disable syringes for fixed-dose immunization (ISO 7886-3:2005)

    Available format(s): 

    Superseded date:  28-05-2020

    Language(s): 

    Published date:  23-09-2009

    Publisher:  Comite Europeen de Normalisation

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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)

    ISO 7886-3:2005 specifies 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. Upon delivering a fixed dose of vaccine the syringe is automatically rendered unusable.ISO 7886-3:2005 does not specify the design of the auto-disable feature, which is left to the discretion of the manufacturerISO 7886-3:2005 is not applicable to syringes for use with insulin (specified in ISO 8537), syringes made of glass (specified in ISO 595), syringes for use with power-driven syringe pumps (specified in ISO 7886-2), auto-disable syringes for variable dose delivery and syringes designed to be prefilled. It does not address compatibility with injection fluids/vaccines.

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

    Committee CEN/TC 205
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By

    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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