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BS EN ISO 8871-2 : 2004

Withdrawn

Withdrawn

View Superseded by

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

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2014

Withdrawn date

06-08-2020

Superseded by

BS EN ISO 8871-2:2020

US$313.37
Excluding Tax where applicable
Summarise this standard

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Withdrawn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

⚠

A newer version of this standard is available.

US$313.37
Excluding Tax where applicable