Sia Analiz
Pyrogenicity
The pyrogenicity test is another test included in the ISO 10993-11 standard, one of the standards within the scope of the biological risk assessment of medical devices. The pyrogenicity test evaluates endotoxin and/or Material Mediated Pyrogenic effect, the potential to cause a pyrogenic response (increase in body temperature) by intravenous administration of a sterile polar extract from medical devices to rabbits. To evaluate the pyrogenic effect, the rabbit pyrogenicity test and in vitro Bacterial Endotoxin (LAL) test are performed in SIA Analysis Laboratories. The rabbit test presents minor nuance differences between European (EU) and American (US) Pharmacopoeias for evaluation. For this purpose, our customers are requested to prepare the test report according to which pharmacopeia.
