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EVS-EN ISO 8871-2:2020

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)

General information
Valid from 15.06.2020
Base Documents
ISO 8871-2:2020; EN ISO 8871-2:2020
Directives or regulations
None
Standard history
Status
Date
Type
Name
15.06.2020
Main
01.07.2014
Amendment
10.12.2004
Main
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.
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Standard monitoring