DS/EN ISO 8871-2
Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 2: Identification and characterization (ISO 8871-2:2020)
active, Most Current
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| Organization: | DS |
| Publication Date: | 8 June 2020 |
| Status: | active |
| Page Count: | 36 |
| ICS Code (Transfusion, infusion and injection equipment): | 11.040.20 |
scope:
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.
Document History
DS/EN ISO 8871-2
June 8, 2020
Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 2: Identification and characterization (ISO 8871-2:2020)
This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices. The physical and...
June 26, 2014
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
Amendment
February 17, 2005
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
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...
Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 2: Identification and characterization (ISO/FDIS 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...
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization - Amendment 1 (ISO 8871-2:2003/Amd 1:2005)
Amendment
Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 2: Identification and characterization (ISO/DIS 8871-2:2019)
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...