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Toxicity screening of candidate materials for the fabrication of a bubble oxygenator: A preliminary report
Authors:P V Vedanarayanan  K Rathinam  A C Fernandez
Affiliation:(1) Division of Material Toxicology, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Biomedical Technology Wing, 695 012 Poojapura, Trivandrum, India
Abstract:The hazards encountered in the clinical use of medical devices and implants have been referred in this paper to emphasise the need for and relevance of carrying out appropriate toxicological investigations before such items are manufactured and marketed. Different formulations of polyvinyl chloride, low density polyethylene, high density polyethylene and polyester fabric were subjected to various tests to determine their biocompatibility/safety for their eventual use as components in a bubble oxygenator. The test methods together with the results obtained are described and discussed.
Keywords:Disposable bubble oxygenator  polyvinyl chloride  safety evaluation  acute systemic toxicity test  haemolysis test  tissue irritation
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