BH GSO ISO 8871-2:2016
ISO 8871-2:2003
Bahraini Standard
Current Edition
·
Approved on
08 February 2016
Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 2: Identification and characterization
BH GSO ISO 8871-2:2016 Files
English
20 Pages
Current Edition
Reference Language
BHD
61.13
BH GSO ISO 8871-2:2016 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.
This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the
relevant product standards.
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