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DIN EN ISO 8871-2:2014-08

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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Superseded date

09-02-2020

Language(s)

German

Published date

01-01-2014

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

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

This standard is included in DIN Handbook 231.

DevelopmentNote
Supersedes DIN ISO 8871 (11/2004)
DocumentType
Standard
Pages
30
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
Supersedes

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)

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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Hardcopy - German
PDF - German
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