SSH EN ISO 8871-4:2006

Pjesët prej elastomeri për parenteralet dhe për pajisjet për përdorime farmaceutike - Pjesa 4: Kërkesat biologjike dhe metodat e provës

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)

Publication date: 7 shk 2007

General information

Current stage: 60.60 Effective date: 7 shk 2007

Originator: DPS

Owner: DPS/KT 316

Type: European Norm

ICS: 11.040.20

Gjuha: anglisht

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Statusi: Publikuar

PDF - 1 190 Lekë

Paper - 1 190 Lekë

CD - 1 190 Lekë

PDF and Paper - 2 380 Lekë

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Scope

ISO 8871-4:2006 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.

SSH EN ISO 8871-4:2006

Pjesët prej elastomeri për parenteralet dhe për pajisjet për përdorime farmaceutike - Pjesa 4: Kërkesat biologjike dhe metodat e provës

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods (ISO 8871-4:2006)

General information

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Scope

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Adopted from EN ISO 8871-4:2006