NEN EN ISO 8871-2 : 2004 AMD 1 2014
Current
The latest, up-to-date edition.
ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
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.
| DevelopmentNote |
Supersedes NEN ISO 8871-2. (09/2004)
|
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 8871-2:2014-08 | Identical |
| NS EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| SN EN ISO 8871-2 : 2005 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 |
| 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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