Standard [WITHDRAWN]
DIN EN ISO 8871-5:2017-03
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016); German version EN ISO 8871-5:2016
- German title
- Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 5: Funktionelle Anforderungen und Prüfung (ISO 8871-5:2016); Deutsche Fassung EN ISO 8871-5:2016
- Publication date
- 2017-03
- Original language
- German
- Pages
- 18
- Publication date
- 2017-03
- Original language
- German
- Pages
- 18
- DOI
- https://dx.doi.org/10.31030/2466018
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Overview
Elastomeric or rubber closures for pharmaceutical use are used in combination with vials and many times in conjunction with piercing devices. There are three functional parameters which are important to the piercing process. These are penetrability, fragmentation and self-sealing. The three functional tests described in this part of ISO 8871 can be used as a reference method for testing elastomeric closures that are pierced using injection needles made from metal. In addition, the aqueous solution tightness test can be used to verify the effectiveness of the sealing of a specific closure/vial combination. This part of ISO 8871 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.
Content
ICS
DOI
This document replaces DIN EN ISO 8871-5:2014-10 .
This document has been replaced by: DIN EN ISO 8871-5:2025-07 .