Draft
International Standard
ISO/DIS 8871-2
Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization
Reference number
ISO/DIS 8871-2
Edition 3
Draft International Standard
ISO/DIS 8871-2
93062
This Draft International Standard is in the enquiry phase with ISO members.
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

  •  : Under development
    : DIS registered [40.00]
  •  : 3
  • ISO/TC 76
    11.040.20 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

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