Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
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
2025-10-14
WI
00205432
Planned document number
prEN ISO 8871-2 rev
Responsible national committee
NA 176-04-05 AA - Elastomeric pharmaceutical packaging and related components
Responsible european committee
CEN/TC 205 - Non-active medical devices
