Díly z elastomerů pro parenterální použití a pro prostředky pro farmaceutické použití - Část 2: Indikace a charakterizace (Norma k přímému použití jako ČSN).
NORMA vydána dne 1.12.2020
Designation standards: ČSN EN ISO 8871-2
Classification mark: 855226
Catalog number: 510927
Publication date standards: 1.12.2020
The number of pages: 36
Approximate weight : 108 g (0.24 lbs)
Country: Czech technical standard
Kategorie: Technické normy ČSN
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