ISO 8871-2:2003

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

Publication date:   Sep 19, 2003

95.99 Withdrawal of Standard   May 14, 2020

General information

95.99 Withdrawal of Standard   May 14, 2020

ISO

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

International Standard

11.040.20   Transfusion, infusion and injection equipment

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Scope

ISO 8871-2:2003 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application.
This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 8871:1990

ABANDON
ISO 8871-2:2003/DAmd 1

NOW

WITHDRAWN
ISO 8871-2:2003
95.99 Withdrawal of Standard
May 14, 2020

CORRIGENDA / AMENDMENTS

ABANDON
ISO 8871-2:2003/DAmd 1

WITHDRAWN
ISO 8871-2:2003/Amd 1:2005

REVISED BY

PUBLISHED
ISO 8871-2:2020