SS-EN-ISO-8871-2 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)

SS-EN-ISO-8871-2 - 2020 EDITION - CURRENT
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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.

To find similar documents by classification:

11.040.20 (Transfusion, infusion and injection equipment Including blood packs Syringes, needles and catheters, see 11.040.25)

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Designation Name

SS-EN ISO 8871-2:2020

Revision Level

2020 EDITION

Status

Current

Publication Date

June 16, 2020

Language(s)

English

Page Count

36

International Equivalent

EN ISO 8871-2:2020(IDT); ISO 8871-2:2020(IDT)