ISO 8871-2:2020

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

Publication date: May 14, 2020

General information

Current stage: 60.60 Effective date: May 14, 2020

Originator: ISO

Owner: ISO/TC 76

Type: International Standard

ICS: 11.040.20

Languages: English French

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Status: Published

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Scope

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.

Life cycle

PREVIOUSLY

Revises
ISO 8871-2:2003

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

NOW

PUBLISHED
ISO 8871-2:2020
60.60 Standard published
May 14, 2020

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