DIN EN ISO 8871-2:2020-09
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization (ISO 8871-2:2020); German version EN ISO 8871-2:2020
| Fecha edición: |
2020-09-01
En Vigor
|
|---|---|
| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | 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. |
| Keywords: | Analysis|Aqueous|Blood transfusion equipment|Characterisations|Chemical analysis and testing|Chemical composition|Classification|Coatings|Containers|Definitions|Designations|Drug administration|Drug containers|Drugs|Elastomers|Identification|Infusions|Injection instruments|Injections|Inspection|Marking|Materials|Means of packaging|Medical equipment|Medical sciences|Medical technology|Packages|Parenteral infusion equipment|Pharmacy|Preparation|Properties|Qualification tests|Rubber|Rubber products|Specification (approval)|Specifications|Stoppers|Storage|Substances|Testing|Transfusions|Vulcanized rubber |
| ICS: | 11.040.20 - Equipo de transfusión, perfusión e inyección |
| CTN: | |
|
Equivalencia Internacional |
Idéntica EN ISO 8871-2:2020 Idéntica ISO 8871-2:2020 |
|
Reemplazo Normas |
Reemplaza a DIN EN ISO 8871-2:2014-08 Reemplaza a DIN EN ISO 8871-2:2019-03 |
Normas citadas
Libros relacionados
Normas relacionadas
Colecciones temáticas relacionadas
