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NBN EN ISO 8871-2 : 2004 AMD 1 2014

Current

Current

The latest, up-to-date edition.

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

Published date

01-12-2013

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)
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.

DevelopmentNote
Supersedes NBN EN ISO 8871. (06/2007)
DocumentType
Standard
PublisherName
Belgian Standards
Status
Current

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