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  • 16/30339096 DC : 0

    NA Status of Standard is Unknown

    BS EN ISO 7886-3 - STERILE HYPODERMIC SYRINGES FOR SINGLE USE - PART 3: AUTO-DISABLE SYRINGES FOR FIXED-DOSE IMMUNIZATION

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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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 Requirements
    6 Cleanliness
    7 Limits for acidity or alkalinity
    8 Limits for extractable metals
    9 Lubricant
    10 Tolerance on nominal capacity
    11 Graduated scale
    12 Barrel
    13 Plunger stopper/plunger assembly
    14 Needle
    15 Performance
    16 Packaging
    17 Information supplied by the manufacturer
    Annex A (normative) - Method for preparation
            of extracts
    Annex B (informative) - Test method for forces
            required to operate piston
    Annex C (normative) - Test method for testing
            auto-disable feature
    Bibliography

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

    Comment Closes On
    Committee CH/84
    Document Type Draft
    Publisher British Standards Institution
    Status NA

    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 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
    ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 594-2:1998 Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings
    ISO 594-1:1986 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements
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