International Standard
ISO 8871-2:2020
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization
Reference number
ISO 8871-2:2020
ISO 8871-2:2020
Edición 2
2020-05
2020-05
© ISO 2024
International Standard
Resumen
This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.
The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.
Ciclo de vida
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Anteriormente
RetiradaISO 8871-2:2003
RetiradaISO 8871-2:2003/Amd 1:2005
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Ahora
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