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.
- Suitable sample matrices
- Medical device
- Required sample quantity
- 6 mL (liquid), or 36 cm^2 (solid)
- Available quality systems
- Accredited testing laboratory, GLP test method
- Standard
- Method expert
Questions? We're happy to help.
Questions? We're happy to help.
Business hours: Mon–Fri 9 AM – 5 PM Finnish time (EST/EEST)
Other tests we offer
Cleaning validation of medical devices by ISO 17664
Irritation testing by ISO 10993-23
Face mask tests according to EN 14683 for type II and type IIR masks
Biocompatibility evaluation of breathing gas pathways by ISO 18562
Genotoxicity - Bacterial reverse mutation test (AMES)
Sterility test by ISO 11737-2: Aerobic bacteria, anaerobic bacteria and fungi
Ethylene oxide (EO) sterilization and sterilization residues by ISO 10993-7
Biological evaluation plan (BEP)
Hemocompatibility testing by ISO 10993-4
Skin sensitization testing by ISO 10993-10
Ask for an offer
Fill in the form, and we'll reply in one business day.
Have questions or need help? Email us at info@measurlabs.com or call our sales team.