I.S. EN ISO 8871-2:2020
Current
The latest, up-to-date edition.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)
Hardcopy , PDF
English
21-06-2020
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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Tests
5 Preparation of samples for testing
6 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 the elastomer identity and verification of the presence of a coating by surface infrared spectroscopy [attenuated total reflection (ATR)]
Bibliography
This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.
| Committee |
TC 76
|
| DocumentType |
Standard
|
| Pages |
40
|
| ProductNote |
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 8871-2:2020 | Identical |
| EN ISO 8871-2:2020 | Identical |
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