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  • DIN EN ISO 8871-2:2014-08

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003 + AMD.1:2005)

    Available format(s):  Hardcopy, PDF

    Superseded date:  02-09-2020

    Language(s):  German

    Published date:  01-01-2014

    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 to EN ISO 8871-2:2003
    Foreword to EN ISO 8871-2:2004/A1:2014
    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)

    This standard is included in DIN Handbook 231.

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

    Development Note Supersedes DIN ISO 8871 (11/2004)
    Document Type Standard
    Publisher German Institute for Standardisation (Deutsches Institut für Normung)
    Status Superseded
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    DIN HDBK 231 : 4ED 2012
    DIN ISO 8536-12:2013-04 Infusion equipment for medical use - Part 12: Check valves (ISO 8536-12:2007 + Amd. 1:2012)

    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
    DIN EN ISO 1183-1:2013-04 PLASTICS - METHODS FOR DETERMINING THE DENSITY OF NON-CELLULAR PLASTICS - PART 1: IMMERSION METHOD, LIQUID PYKNOMETER METHOD AND TITRATION METHOD (ISO 1183-1:2012)
    DIN ISO 48:2016-09 Rubber, vulcanized or thermoplastic - Determination of hardness (hardness between 10 IRHD and 100 IRHD) (ISO 48:2010)
    ISO 8536-6:2016 Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
    DIN EN ISO 8871-1:2004-11 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLE IN AQUEOUS AUTOCLAVATES
    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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