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ILNAS-EN ISO 8871-2:2020 Edition 06/2020
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)
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  • 36.2 / copy
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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.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 205 : Non-active medical devices

Implementation

start of the vote on the project    14/02/2019   date of ratification (dor)    21/04/2020
end of the vote on the project    09/05/2019   date of anouncement (doa)    30/09/2020
start of the vote on the final project    23/01/2020   date of publication (dop)    31/12/2020
end of the vote on the final project    20/03/2020   date of withdrawal (dow)    31/12/2020


Publication Official Journal
of the Grand-Duchy of Luxembourg
24/12/2020
Reference Mémorial A N° 1077

Relations

Relations to older standards
ILNAS-EN ISO 8871-2:2004/A1:2014
ILNAS-EN ISO 8871-2:2004

Relations to international standards
ISO 8871-2 
ISO 8871-2:2020 

International Classification for Standards (ICS codes) :

11.040.20 : Transfusion, infusion and injection equipment

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