Material Mediated Pyrogenicity Testing

Material medicated pyrogenicity per ISO 10993 Part 11

Pyrogenicity testing assesses whether medical device materials or their extracts induce fever-producing substances (pyrogens), mainly bacterial endotoxins, which can cause harmful febrile responses when introduced into the body. ISO 10993-11 includes pyrogenicity as part of systemic toxicity evaluation.

Academic research has not formally defined material-mediated pyrogenicity. That being said, both academically and in the field, material-mediated pyrogenicity is considered to occur due to contamination by a group of pyrogens outside of those comprising endotoxins but within those constituting non-endotoxin pyrogens. More specifically, material-mediated pyrogenicity is thought to derive from surfaces or materials of medical devices as well as contaminations that may have arisen during production or packaging. Material-mediated pyrogenicity is understood to stem from contaminants of mold releases, processing aids, cutting fluids, or cleaning agents — among others.