Sia Analysis
Pyrogenicity
Pyrogenicity test is another test included in ISO 10993-11 standard, which is one of the standards within the scope of biological risk assessment of medical devices. Pyrogenicity test evaluates endotoxin and/or material mediated pyrogen effect, potential of causing pyrogenic response (increase in body temperature) as a result of intravenous application of sterile polar extract obtained from medical devices to rabbits. In order to evaluate pyrogenic effect, rabbit pyrogenicity test and vitro Bacterial Endotoxin (LAL) test is performed.
Rabbit test presents minor nuances in terms of evaluation between European (EU) and American (US) Pharmacopoeias. For this purpose, our customers are requested to specify which pharmacopoeia the test report should be prepared according to.