UNE-EN ISO 8871-2:2020
Current
The latest, up-to-date edition.
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)
Hardcopy , PDF
English, Spanish, Castilian
23-12-2020
This document specifies evaluation procedures applicable to elastomeric parts including coatedstoppers used for drug containers and medical devices in order to guarantee the product identity.The physical and chemical test procedures specified in this document permit the determinationof the typical characteristics of elastomeric parts, and can serve as a basis for agreements betweenmanufacturer and user regarding the product consistency in subsequent supplies. An appropriate set oftests is selected, depending upon the type of elastomer and its application.This document does not specify other requirements for elastomeric parts. These are laid down in therelevant product standards.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
32
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| ISO 8871-2:2020 | Identical |
| EN ISO 8871-2:2020 | Identical |
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