Pyrogenicity testing by ISO 10993-11

Pyrogenicity assessment by ISO 10993-11 to evaluate the material-mediated pyrogenic (i.e., fever-inducing) potential of medical devices.

Material-mediated pyrogenicity tests focus on non-endotoxin-related substances, including bacterial exotoxins, endogenous pyrogens, prostaglandin, neurotransmitters, and metal salts. These can be studied using in vitro assays, where the fever-inducing potential is evaluated using cells, or in vivo rabbit pyrogen tests, where the animal's body temperature is monitored upon exposure to device extracts.

Measurlabs provides testing using the following methods:

• Material-mediated pyrogenicity - In vivo (rabbit)

• Material-mediated pyrogenicity - In vitro (MAT, Monocyte Activation Test)

Please ask for a quote for your medical device.

We also offer Bacterial endotoxin tests (ISO 11737-3) to evaluate endotoxin-related pyrogenicity.