NEN-ISO 8871-2
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
inactive, Most Current
| Organization: | NEN |
| Publication Date: | 1 November 2003 |
| Status: | inactive |
| Page Count: | 30 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
scope:
This part of ISO 8871 specifies evaluation procedures applicable 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 part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may 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 rubber and its application.
Document History
NEN-ISO 8871-2
November 1, 2003
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
This part of ISO 8871 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples...