SSH EN ISO 8871-5:2016

Pjesët e elastomerit për parenteralet dhe për pajisjet për përdorim farmaceutik - Pjesa 5: Kërkesat funksionale dhe testimi (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: 20 tet 2017

General information

Current stage: 60.60 Effective date: 17 korr 2017

Originator: DPS

Owner: DPS/KT 205

Type: European Norm

ICS: 11.040.20

Gjuha: anglisht

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Statusi: Publikuar

PDF - 2 677 Lekë

Paper - 2 677 Lekë

CD - 2 677 Lekë

PDF and Paper - 5 354 Lekë

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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

WITHDRAWN
SSH EN ISO 8871-5:2014

NOW

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

SSH EN ISO 8871-5:2016

Pjesët e elastomerit për parenteralet dhe për pajisjet për përdorim farmaceutik - Pjesa 5: Kërkesat funksionale dhe testimi (ISO 8871-5:2016)

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

General information

Buying

Scope

Life cycle

PREVIOUSLY

NOW

Related project

Adopted from EN ISO 8871-5:2016

Adopted from ISO 8871-5:2016