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EVS-EN ISO 8871-2:2004

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization

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Kehtetu alates 15.06.2020
Alusdokumendid
ISO 8871-2:2003; EN ISO 8871-2:2004
Direktiivid või määrused
puuduvad
Standardi ajalugu
Staatus
Kuupäev
Tüüp
Nimetus
15.06.2020
Põhitekst
01.07.2014
Muudatus
10.12.2004
Põhitekst
This part of ISO 8871 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application.
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EVS-EN ISO 14405-2:2011

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Kehtetu alates 01.02.2019
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EVS-EN ISO 8871-2:2004/A1:2014

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005)
Kehtetu alates 15.06.2020
Põhitekst

EVS-EN ISO 8871-5:2014

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2005)
Kehtetu alates 06.12.2016