• ONORM EN ISO 7886-4 : 2010

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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 4: SYRINGES WITH RE-USE PREVENTION FEATURE

    Available format(s): 

    Withdrawn date:  15-06-2019

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Osterreichisches Normungsinstitut/Austrian Standards

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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 Types of syringe
    6 Cleanliness
    7 Limits for acidity or alkalinity
    8 Limits for extractable metals
    9 Lubricant
    10 Tolerance on graduated capacity
    11 Graduated scale
    12 Barrel
    13 Piston/plunger assembly
    14 Syringe nozzle/needle
    15 Performance
    16 Packaging
    17 Labelling
    Annex A (normative) Method for preparation of extracts
    Annex B (normative) Test method for testing re-use
            prevention feature for RUP syringes
    Annex C (informative) Environmental aspects
    Annex ZA (informative) Relationship between this European
             Standard and the Essential Requirements of EU
             Directive 93/42/EEC Medical devices
    Bibliography

    Abstract - (Show below) - (Hide below)

    Describes requirements for sterile single-use hypodermic syringes made of plastic materials with or without needle, and intended for the aspiration of fluids or for the injection of fluids immediately after filling and of design such that the syringe can be rendered unusable after use.

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

    Document Type Standard
    Publisher Osterreichisches Normungsinstitut/Austrian Standards
    Status Withdrawn
    Superseded By

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

    ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
    ISO 780:2015 Packaging Distribution packaging Graphical symbols for handling and storage of packages
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
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