Elastomeric parts for parenterals and for devices for pharmaceutical use Functional requirements and testing

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

30-11-2016

Publisher

British Standards Institution

This part of ISO8871 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 ISO8536-2 and in ISO8536-6.

Committee	CH/212
DevelopmentNote	Supersedes 04/30086336 DC. (09/2014) Supersedes 15/30324254 DC. (12/2016)
DocumentType	Standard
Pages	22
PublisherName	British Standards Institution
Status	Current
Supersedes	BS EN ISO 8871-5:2014 04/30086336 DC : 0 15/30324254 DC : 0

Standards	Relationship
EN ISO 8871-5:2016	Identical
ISO 8871-5:2016	Identical

ISO 8536-2:2010	Infusion equipment for medical use — Part 2: Closures for infusion bottles
ISO 8362-4:2011	Injection containers and accessories Part 4: Injection vials made of moulded glass
ISO 8536-6:2016	Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
ISO 8362-3:2001	Injection containers and accessories Part 3: Aluminium caps for injection vials
ISO 8362-6:2010	Injection containers and accessories Part 6: Caps made of aluminium-plastics combinations for injection vials
ISO 7864:2016	Sterile hypodermic needles for single use — Requirements and test methods
ISO 8362-1:2009	Injection containers and accessories Part 1: Injection vials made of glass tubing