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Title: Mandatory biological testing of Spictra Cardiotomy Reservoir.
Authors: Rathinam, K
Mohanan, PV
Keywords: Biological Evaluation
Issue Date: 1992
Publisher: Journal of biomaterials applications
Citation: Journal of biomaterials applications. 6; 4; 319-25
Abstract: Disposable rigid Spictra Cardiotomy Reservoir is one of the units used in the extracorporeal techniques during open-heart surgery. It was designed, developed, and tested by different groups of our Institute as an indigenous product to offset the prohibitive cost of the imported one. The finished device was subjected to mandatory biological tests, such as pyrogen (in vivo rabbits and in vitro Limulus Amebocyte Lysate test) and sterility tests. It can be concluded from the case study that the device deemed to have passed the test for apyrogenicity and sterility.
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