BS EN ISO 8871-2 : 2004
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
Hardcopy , PDF
English
01-01-2014
08-06-2020
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Withdrawn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 |
| Standards | Relationship |
| 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 |
| 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 |
| EN ISO 8871-2:2004 | Equivalent |
| UNE-EN ISO 8871-2:2005 | Identical |
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