Committee Draft
ISO/CD 8871-2
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization
Reference number
ISO/CD 8871-2
Edition 3
© ISO 2026
Committee Draft
Under development
A draft is being reviewed by the committee.
Will replace ISO 8871-2:2020

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.

General information

  • Status
     : Under development
    Stage
    : CD approved for registration as DIS [30.99]
  • Edition
     : 3
  • Technical Committee :
    ISO/TC 76
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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