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SN EN ISO 8871-2 : 2005 AMD 1 2014

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

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

Superseded date

10-09-2021

Superseded by

SN EN ISO 8871-2:2020

Published date

12-01-2013

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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.

Committee
INB/NK 2205
DevelopmentNote
Supersedes SNV NF EN ISO 8871 (04/2005) Supersedes SNV NF S93-102. (10/2006)
DocumentType
Standard
PublisherName
Swiss Standards
Status
Superseded
SupersededBy
Supersedes

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