I.S. EN ISO 8871-2:2004
Superseded
View Superseded by
ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003)
Hardcopy , PDF
English
01-01-2004
14-07-2020
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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
Describes 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 I.S. EN ISO 8871 (11/2004)
|
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| DIN EN ISO 8871-2:2014-08 | Identical |
| NBN EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| NS EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| NF EN ISO 8871-2 : 2005 AMD 1 2014 | Identical |
| NEN EN ISO 8871-2 : 2004 AMD 1 2014 | Identical |
| ISO 8871-2:2003 | Identical |
| BS EN ISO 8871-2 : 2004 | Identical |
| EN ISO 8871-2:2004 | Equivalent |
| UNE-EN ISO 8871-2:2005 | Identical |
A newer version of this standard is available.
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