SSH 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)

Publication date: Oct 20, 2017

General information

Current stage: 60.60 Effective date: Jul 17, 2017

Originator: DPS

Owner: DPS/KT 205

Type: European Norm

ICS: 11.040.20

Languages: English

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Status: Published

PDF - ALL 2,677

Paper - ALL 2,677

CD - ALL 2,677

PDF and Paper - ALL 5,354

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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.

Life cycle

PREVIOUSLY

Replaces
SSH EN ISO 8871-5:2014

NOW

PUBLISHED
SSH EN ISO 8871-5:2016
60.60 Standard published
Jul 17, 2017

Related project

Adopted from EN ISO 8871-5:2016

Adopted from ISO 8871-5:2016

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