ISO-8871-1 › Elastomeric parts for parenterals and for devices for pharmaceutical use -- Part 1: Extractables in aqueous autoclavates
The following bibliographic material is provided to assist you with your purchasing decision:
ISO 8871-1:2003 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use.
It specifies a series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclavates and describes the various fields of application for elastomeric parts. Dimensions and functional characteristics are specified in the relevant International Standards. Required properties as specified in this part of ISO 8871 are regarded as minimum requirements.
Elastomeric parts for empty syringes for single use are excluded from the scope of this part of ISO 8871 as they are not in contact with the injected preparation for a significant length of time.
Compatibility studies with the intended preparation have to be performed before the approval for final use can be given; however, this part of ISO 8871 does not specify procedures for carrying out compatibility studies.
To find similar documents by classification:
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
MIL-STD-810Environmental Engineering Considerations and Laboratory Tests
ISO-11040-4
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
ASQ-Z1.4
Sampling Procedures and Tables for Inspection by Attributes - Paper Format - Reaffirmed in 2018
Document Number
ISO 8871-1:2003
Revision Level
1ST EDITION
Status
Current
Publication Date
Oct. 1, 2003
Committee Number
ISO/TC 76