How To Meet Requirements Of Biocompatibility Testing?
Biocompatibility testing is an important part of medical device development that ensures the safety and effectiveness of a device before it can enter clinical trials. The general goal of biomaterials testing is to ensure that materials used in medical devices are non-toxic, non-inflammatory, and not able to break down into any toxic fragments during normal use. Biocompatibility testing has become more rigorous over time as regulators have recognized the risks posed by untested or poorly tested devices. Failure to meet any of these standards may require you to make additional changes before you can proceed with the commercialization of your device. These days biocompatibility for medical devices testing has become mandatory. · Cytotoxicity – ISO 10993 Part 5 The cytotoxicity test is designed to determine whether material or device is toxic to human cells. This test is often performed on the materials used to make the device itself, but can also extend