EN ISO 8871-5:2016
Withdrawn
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)
11-23-2016
05-31-2017
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
ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.
| Committee |
CEN/TC 205
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| NBN EN ISO 8871-5 : 2014 | Identical |
| BS EN ISO 8871-5:2016 | Identical |
| NEN EN ISO 8871-5 : 2016 | Identical |
| I.S. EN ISO 8871-5:2016 | Identical |
| NS EN ISO 8871-5 : 2016 | Identical |
| ISO 8871-5:2016 | Identical |
| SS-EN ISO 8871-5:2016 | Identical |
| PN EN ISO 8871-5 : 2017 | Identical |
| NF EN ISO 8871-5 : 2017 | Identical |
| DIN EN ISO 8871-5:2015-08 (Draft) | Identical |
| DS EN ISO 8871-5 : 2016 | Identical |
| DIN EN ISO 8871-5:2017-03 | Identical |
| UNE-EN ISO 8871-5:2017 | Identical |