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    I.S. EN ISO 7886-1:1998

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1: SYRINGES FOR MANUAL USE (ISO 7886-1:2017)

    Available format(s):  Hardcopy, PDF

    Superseded date:  03-06-2018

    Language(s):  English

    Published date:  01-01-1998

    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)

    National Foreword
    European foreword
    Endorsement notice
    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Nomenclature
    5 General requirements
    6 Extraneous matter
    7 Lubricant
    8 Tolerance on graduated capacity
    9 Graduated scale
    10 Barrel
    11 Plunger stopper/plunger assembly
    12 Nozzle
    13 Performance
    14 Packaging
    15 Information supplied by the manufacturer
    Annex A (normative) - Method for preparation
            of extracts
    Annex B (normative) - Test method for air leakage
            past syringe plunger stopper during aspiration,
            and for separation of plunger stopper and plunger
    Annex C (normative) - Method for determination of
            dead space
    Annex D (normative) - Test method for liquid leakage
            at syringe plunger stopper under compression
    Annex E (informative) - Test method for the determination
            of forces required to operate the piston
    Annex F (informative) - Test method for the quantity of
            silicone
    Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential Requirements
             of Directive 93/42/EEC [OJ L 169] aimed to be covered

    Abstract - (Show below) - (Hide below)

    Defines requirements for sterile single-use hypodermic plastic syringes for aspiration or injecting of fluids immediately after filling. Does not include syringes to be used with insulin, single-use glass syringes, syringes used with power-driven syringe pumps, prefilled with injection by the manufacturer or supplied as a kit for filling by a pharmacist.

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

    Development Note 2018 edition incorporates corrigendum 2018. (05/2018)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By

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

    EN ISO 23908:2013 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 23908:2011)
    ISO 11607-2:2006 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
    ISO 15223-2:2010 Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
    ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
    ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods
    ISO 384:2015 Laboratory glass and plastics ware Principles of design and construction of volumetric instruments
    ISO 8601:2004 Data elements and interchange formats Information interchange Representation of dates and times
    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 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
    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 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN ISO 80369-7:2017 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications (ISO 80369-7:2016, Corrected version 2016-12-01)
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