Standard Swedish standard · SS-EN ISO 8871-5:2016

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016)

Status: Valid

Scope
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.

Subjects

Transfusion, infusion and injection equipment (11.040.20)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-8023818

Edition: 2

Approved: 11/29/2016

No of pages: 24

Replaces: SS-EN ISO 8871-5:2014