Toxicological evaluation of medical devices
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Medical device testing expert Elina Tenhunen is happy to help.
Toxicological evaluation by ISO 10993 standards
Measurlabs offers all the toxicological tests by ISO 10993 that are required to confirm the biocompatibility of medical devices in the EU, the US, and other markets. The testing options include:
Toxicological risk assessment of medical devices by ISO 10993-17
Acute, subacute, chronic, and subchronic systemic toxicity testing by ISO 10993-11
Material-mediated pyrogenicity assessment by ISO 10993-11
Genotoxicity testing by ISO 10993-3
The extent of toxicological testing a new medical device requires depends on its intended use, including body contact site and contact duration. These factors, as well as the region where the device is brought to market, also determine which tests can be performed using in vitro methods.
The procedure for the toxicological evaluation is always formulated on a case-by-case basis. Our experts will help you choose the appropriate tests and testing conditions for your device, so do not hesitate to get in touch.
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