DANSK DS/EN ISO 8871-2 PDF

This standard specifies evaluation procedures to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this standard permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreement between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending on the type of rubber and its application.