ISO 8871:1990Withdrawn

Elastomeric parts for aqueous parenteral preparations

Éléments en élastomère pour préparations aqueuses parentérales

This edition has been replaced by ISO 8871-3:2003, ISO 8871-1:2003, ISO 8871-4:2006.

Abstract / scope

The elastomeric parts generally called "rubber" may vary considerably in their composition with regard to fillers, softeners, pigments and other auxiliary ingredients. This standard defines procedures for identifying and classifying elastomeric parts for primary packs and medical devices used in direct contact with the preparations. To avoid any affection of the preparations the 12 normative annexes specify test methods for individual applications.

Life cycle

Amendments & corrigenda

ISO 8871:1990/Amd 1:1995WithdrawnElastomeric parts for aqueous parenteral preparations — Amendment 1International Standard · Published 5 Oct 1995 · ISO/TC 76

Replaces

ISO 8871:1988WithdrawnElastomeric parts for aqueous parenteral preparationsInternational Standard · Published 10 Nov 1988 · ISO/TC 76

Replaced by

ISO 8871-3:2003PublishedElastomeric parts for parenterals and for devices for pharmaceutical use — Part 3: Determination of released-particle countInternational Standard · Published 31 Jul 2003 · ISO/TC 76ISO 8871-2:2003WithdrawnElastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterizationInternational Standard · Published 19 Sep 2003 · ISO/TC 76ISO 8871-1:2003PublishedElastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavatesInternational Standard · Published 19 Sep 2003 · ISO/TC 76ISO 8871-5:2005WithdrawnElastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testingInternational Standard · Published 15 Aug 2005 · ISO/TC 76ISO 8871-4:2006PublishedElastomeric parts for parenterals and for devices for pharmaceutical use — Part 4: Biological requirements and test methodsInternational Standard · Published 14 Jun 2006 · ISO/TC 76