Biocompatibility is, by definition, a measurement of how compatible a device is with a biological system. The purpose of performing biocompatibility testing is to determine the fitness of a device for human use, and to see whether use of the device can have any potentially harmful physiological effects. As stated by the International Organization of Standards (ISO):
“The primary aim of this part of ISO 10993 is the protection of humans from potential biological risks arising from the use of medical devices.” (ISO 10993-1:2009)
Typically, material characterization and analysis of a device’s components are conducted prior to any biological testing. This involves extracting leachable materials from the device or components at an elevated temperature, and analyzing the leachable extracts for potentially harmful chemicals or cytotoxicity.
Once in vitro testing has been completed, in vivo biological testing can be done based upon the device’s intended use. This testing can range from skin irritation testing to hemocompatibility and implantation testing. Turnaround time for tests can range from three weeks to greater than several months, depending on the specific test data needed. Subchronic or chronic implantation testing can last even longer.
Pacific BioLabs has been assisting medical device companies with FDA IDE and 510k as well as international regulatory submissions for many years. We offer testing performed according to ISO 10993, compliant with major regulatory bodies. Our animal programs are AAALAC accredited, and we carry ISO 9001:2008 and ISO 13485:2003 certifications.
For an in-depth exploration of biocompatibility, methods, and related tests, visit our Learning Center section on Assessing Biocompatibility.
Available Biocompatibility Tests