60.60 Standard published Jun 3, 2020
CEN
CEN/TC 205 Non-active medical devices
European Norm
11.040.20 Transfusion, infusion and injection equipment
Published
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.
PUBLISHED
EN ISO 8871-2:2020
60.60
Standard published
Jun 3, 2020
