DIN Standards Committee Health Technologies
DIN EN ISO 8871-2
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2003 + Amd.1:2005); German version EN ISO 8871-2:2004 + A1:2014
Elastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung - Teil 2: Identifizierung und Charakterisierung (ISO 8871-2:2003 + Amd.1:2005); Deutsche Fassung EN ISO 8871-2:2004 + A1:2014
Overview
This document (EN ISO 8871-2:2004 + A1:2014) includes the German version of Amendment 1 (ISO 8871-2:2003/Amd1:2005) that has been taken over as EN ISO 8871-2:2004/A1:2014 by CEN/TC 205 "Non-active medical devices". DIN EN ISO 8871-2 specifies procedures applicable to elastomeric parts used for drug containers and medical devices in order to ensure the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures included in this standard permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. With Amendment 1, an informative Annex on a method for the determination of a fingerprint by surface infrared spectroscopy has been added.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-04-05 AA - Elastomeric pharmaceutical packaging and related components
