ISO 8871-2:2020

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization

Digital Document2020 edition2020Purchase Options

Referenced standards

ISO 247-1:2018ISO 2781:2018ISO 48-4ISO 8871-1
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ISO 8871-2:2020

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization

Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization

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.

Edition2020
Standard Part No2
Published Date2020
Published ByInternational Standardization Organisation
Page Count23