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  • DIN EN ISO 7886-4 E : 2010

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 4: SYRINGES WITH RE-USE PREVENTION FEATURE

    Available format(s):  Hardcopy, PDF

    Superseded date:  03-08-2019

    Language(s):  English

    Published date:  01-01-2010

    Publisher:  German Institute for Standardisation (Deutsches Institut für Normung)

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

    National foreword
    National Annex NA (informative) - Bibliography
    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
    Bibliography
    Annex ZA (informative) - Relationship between this European
             Standard and the Essential Requirements of
             EU Directive 93/42/EEC on medical devices

    Abstract - (Show below) - (Hide below)

    Describes requirements for sterile single-use hypodermic syringes made of plastics 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 German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Superseded By

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

    ISO 7886-3:2005 Sterile hypodermic syringes for single use Part 3: Auto-disable syringes for fixed-dose immunization
    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 7886-2:1996 Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps
    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
    DIN EN ISO 9626 E : 2016 STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS (ISO 9626:2016)
    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
    DIN EN ISO 780 E : 2016 PACKAGING - DISTRIBUTION PACKAGING - GRAPHICAL SYMBOLS FOR HANDLING AND STORAGE OF PACKAGES (ISO 780:2015)
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    DIN ISO 3696:1991-06 WATER FOR ANALYTICAL LABORATORY USE - SPECIFICATION AND TEST METHODS
    DIN EN ISO 7886-1 E : 1997 STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 1: SYRINGES FOR MANUAL USE
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