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ISO 8871-2:2020

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

General information

Valid from 14.05.2020
ICS Groups
11.040.20 Transfusion, infusion and injection equipment
Directives or regulations
None

Standard history

Status
Date
Type
Name
14.05.2020
Main
ISO 8871-2:2020
22.07.2005
Amendment
ISO 8871-2:2003/Amd 1:2005
19.09.2003
Main
ISO 8871-2:2003
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.

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Standard monitoring
English (PDF 927 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English