ISO 8871-2:2020

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

Standard Details

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 : Published

Standard Type: Main

Document No: ISO 8871-2:2020

Document Year: 2020

Pages: 23

Edition: 2

Section Volume:
ISO/TC 76. Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

ICS:
11.040.20 Transfusion, infusion and injection equipment

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ISO 8871-2:2020

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ISO 8871-2:2003

ISO 8871-2:2020

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