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BS EN ISO 8871-2 : 2004

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
Amended by

BS EN ISO 8871-2:2004+A1:2014

Available format(s)

Hardcopy , PDF

Withdrawn date

06-08-2020

Language(s)

English

Published date

01-01-2014

Publisher

British Standards Institution

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

Provides 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.

Committee
CH/212
DevelopmentNote
Together with BS EN ISO 8871-1 and BS EN ISO 8871-3 it supersedes BS EN ISO 8871. (09/2004) 2004 Edition Re-Issued in July 2014 & incorporates AMD 1 2014. (07/2014)
DocumentType
Standard
Pages
34
PublisherName
British Standards Institution
Status
Withdrawn
SupersededBy
Supersedes

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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PDF - English
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