Abstract

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.

Begin

2025-10-27

WI

00205432

Planned document number

DIN EN ISO 8871-2

Project number

17600203

Responsible national committee

NA 176-04-05 AA - Elastomeric pharmaceutical packaging and related components  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 76/WG 4 - Elastomeric parts and components and related secondary packaging components  

draft standard

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO/DIS 8871-2:2026); German and English version prEN ISO 8871-2:2026
2027-01
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previous edition(s)

Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020); German version EN ISO 8871-2:2020
2020-09

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