Skip to main content
Tagasi

EVS-EN ISO 8871-1:2004

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates

Üldinfo

Kehtiv alates 10.12.2004
Alusdokumendid
ISO 8871-1:2003; EN ISO 8871-1:2004
Direktiivid või määrused
puuduvad

Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
10.12.2004
Põhitekst
This part of ISO 8871 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.

Nõutud väljad on tähistatud *

*
*
*
PDF
19,52 € koos KM-ga
Paber
19,52 € koos KM-ga
Sirvi standardit alates 2,44 € koos KM-ga
Standardi monitooring

Teised on ostnud veel

Põhitekst

EVS-EN ISO 8871-4:2006

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods
Uusim versioon Kehtiv alates 08.08.2006
Põhitekst

EVS-EN ISO 8872:2004

Aluminium caps for transfusion, infusion and injection bottles - General requirements and test methods
Kehtetu alates 01.12.2022
Põhitekst

EVS-EN ISO 8871-2:2004

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
Kehtetu alates 15.06.2020
Põhitekst

EVS-EN ISO 8871-3:2004

Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count
Uusim versioon Kehtiv alates 12.10.2004