Back

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
Directives or regulations
None
Standard history
Status
Date
Type
Name
14.05.2020
Main
22.07.2005
Amendment
19.09.2003
Main
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.
*
*
*
PDF
130.33 € incl tax
Paper
130.33 € incl tax
Standard monitoring
Customers who bought this item also bought
Main + corrigendum

EVS-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Newest version Valid from 02.03.2016
Main

EVS-EN ISO 11608-1:2015

Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems (ISO 11608-1:2014)
Newest version Valid from 04.02.2015
Main

ISO 8871-1:2003

Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 1: Extractables in aqueous autoclavates
Newest version Valid from 19.09.2003
Main

ISO 11040-4:2015

Prefilled syringes -- Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
Newest version Valid from 02.04.2015