title: Mandatory biological testing of Spictra Cardiotomy Reservoir.
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.
authors.affiliation: Division of Toxicological Screening of Materials, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Kerala, India.
authors.forename: K
authors.initials: K
authors.lastname: Rathinam
authors.forename: P V
authors.initials: PV
authors.lastname: Mohanan
mesh_terms: D000818:Animals; D001207:Asepsis; D001681:Biological Assay; D006348:Cardiac Surgical Procedures / Q000295:instrumentation*; D005112:Extracorporeal Circulation / Q000295:instrumentation*; D005260:Female; D006801:Humans; D008033:Limulus Test; D008297:Male; D008422:Materials Testing; D011749:Pyrogens; D011817:Rabbits
chemical_list: D011749:Pyrogens