DIN EN ISO 8871-5:2017-03
Superseded
View Superseded by
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
Hardcopy , PDF
English, German
01-03-2017
01-07-2025
National foreword
National Annex NA (informative) - Bibliography
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 |
19
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ISO 8871-5:2016 | Identical |
| EN ISO 8871-5:2016 | Identical |