UNE EN ISO 8871-2:2020
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020)
Elementos elastoméricos para productos de administración parenteral y para productos de uso farmacéutico. Parte 2: Identificación y caracterización. (ISO 8871-2:2020).
| Standard number: | UNE EN ISO 8871-2:2020 |
| Pages: | 32 |
| Released: | 2020-12-23 |
| Status: | Standard |
| Pages (Spanish): | 33 |
UNE EN ISO 8871-2:2020
This document specifies evaluation procedures applicable to elastomeric parts including coated stoppers 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 determination of the typical characteristics of elastomeric parts, and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests 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 the relevant product standards.
