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I.S. EN ISO 8871-2:2004

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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)
Available format(s)

Hardcopy , PDF

Superseded date

07-14-2020

Language(s)

English

Published date

01-01-2004

Preview

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.

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

Describes 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.

DevelopmentNote
Supersedes I.S. EN ISO 8871 (11/2004)
DocumentType
Standard
Pages
46
PublisherName
National Standards Authority of Ireland
Status
Superseded
SupersededBy

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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