Objavljen
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.
OBJAVLJEN
ISO 8871-2:2020
90.20
Početak postupka preispitivanja standarda
15. 4. 2025.
Delovi od elastomera za parenteralne preparate i sredstva za farmaceutsku upotrebu – Deo 2:Identifikacija i karakterizacija
60.60 Standard objavljen
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