DIN Standards Committee Health Technologies
DIN EN ISO 8871-5
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
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
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.
Document: references other documents
Responsible national committee
NA 176-04-05 AA - Elastomeric pharmaceutical packaging and related components
Responsible european committee
CEN/TC 205 - Non-active medical devices
Responsible international committee
ISO/TC 76/WG 4 - Elastomeric parts and components and related secondary packaging components
