ISO 8871-2:2020 PDF

Scope: 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.

ISO 8871-2:2020 Referenced Document

ISO 247-1:2018 Rubber - Determination of ash - Part 1: Combustion method
ISO 2781:2018 Rubber, vulcanized or thermoplastic - Determination of density
ISO 48-4 Rubber, vulcanized or thermoplastic - Determination of hardness - Part 4: Indentation hardness by durometer method (Shore hardness)
ISO 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates

2020 ISO 8871-2:2020 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization
2005 ISO 8871-2:2003/Amd 1:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization; Amendment 1
2003 ISO 8871-2:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization