SN EN ISO 8871-2 : 2005 AMD 1 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003/AMD 1:2005)
10-09-2021
12-01-2013
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.
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Superseded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 |
Standards | Relationship |
DIN EN ISO 8871-2:2014-08 | Identical |
NS EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
I.S. EN ISO 8871-2:2004 | Identical |
NF EN ISO 8871-2 : 2005 AMD 1 2014 | Identical |
UNI EN ISO 8871-2 : 2014 | Identical |
NEN EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
ISO 8871-2:2003 | Identical |
NBN EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
BS EN ISO 8871-2 : 2004 | Identical |
UNE-EN ISO 8871-2:2005 | Identical |
ONORM EN ISO 8871-2 : 2014 | Identical |
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