I.S. EN ISO 8871-5:2016
Current
The latest, up-to-date edition.
ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016)
Hardcopy , PDF
English
01-01-2016
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.
National foreword
European foreword
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Preparation of elastomeric closures for testing
Annex A (normative) - Test for penetrability
Annex B (normative) - Test for fragmentation
Annex C (normative) - Test for self-sealing and dye
solution tightness
Annex D (normative) - Test for dye solution tightness
Bibliography
Defines requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
| DocumentType |
Standard
|
| Pages |
28
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| EN ISO 8871-5:2016 | Identical |
| ISO 8871-5:2016 | Identical |
| BS EN ISO 8871-5:2016 | Equivalent |
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