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  • UNI EN ISO 8871-2 : 2014

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION

    Available format(s): 

    Superseded date:  30-05-2022

    Language(s): 

    Published date:  01-01-2014

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Tests
    4 Preparation of samples for testing
    5 Reagents and materials
    Annex A (informative) - Identification of
            elastomeric material by pyrolysis IR
    Annex B (informative) - Determination of
            compression set
    Annex C (informative) - Swelling behaviour in oils
    Annex D (informative) - Development of a fingerprint
            by gas chromatography
    Annex E (informative) - Analysis of volatile
            components by headspace gas chromatography
    Annex F (informative) - Determination of residual moisture
    Annex G (informative) - Determination of a fingerprint by
            thermal gravimetry (TG)
    Annex H (informative) - Determination of a fingerprint by
            surface infrared spectroscopy (ATR, attenuated total
            reflection)
    Bibliography

    Abstract - (Show below) - (Hide below)

    Defines evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies.

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

    Committee U42.01
    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

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

    ISO 11040-2:2011 Prefilled syringes Part 2: Plunger stoppers for dental local anaesthetic cartridges
    ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
    ISO 8362-2:2015 Injection containers and accessories — Part 2: Closures for injection vials
    ISO 8536-2:2010 Infusion equipment for medical use — Part 2: Closures for infusion bottles
    ISO 11040-5:2012 Prefilled syringes — Part 5: Plunger stoppers for injectables
    ISO 8536-6:2016 Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
    ISO 8362-5:2016 Injection containers and accessories Part 5: Freeze drying closures for injection vials
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO 9924-1:2016 Rubber and rubber products — Determination of the composition of vulcanizates and uncured compounds by thermogravimetry — Part 1: Butadiene, ethylene-propylene copolymer and terpolymer, isobutene-isoprene, isoprene and styrene-butadiene rubbers
    ISO 247:2006 Rubber Determination of ash
    ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
    ISO 2781:2008 Rubber, vulcanized or thermoplastic Determination of density
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