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

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

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1   Scope

This document specifies requirements and test methods for functional parameters of closures used in combination with vials and when pierced by an injection needle.

NOTE Functional testing with spikes is specified in ISO 8536-2, ISO 8536-6, ISO 8362-1 and ISO 8362-4.