Medical device testing can cover a wide variety of areas – from qualifying materials and ensuring their safety for human use, to validating sterilization or cleaning and disinfection programs, and also ensuring that final products are free of microorganisms.
For some testing categories, GLP, or Good Laboratory Practice regulations, need to be applied to studies. Other studies may need to be conducted under GMP, or Good Manufacturing Practice regulations.
Categories of Medical Device Testing
Biocompatibility Testing procedures help device engineers screen materials for safety characteristics. Finished product testing per ISO 10993 provides documentation of device safety for regulatory approvals.
USP Class Plastics Tests are sometimes performed on materials, but medical devices require a more rigorous, full suite of biocompatibility testing.
Sterilization Validation studies are required to assure the efficacy of sterilization cycles, whether gamma, e-beam, ethylene oxide or steam. Where dosimetric or parametric release is not practical, lot release sterility testing may be necessary to demonstrate that safety requirements have been met.
Sterility Tests include bioburden, microbial identification, dose audits, testing for sterility, as well as endotoxins (LAL) tests.
Reusable Device Validations include cleaning, disinfection, and sterilization validation studies conducted on reusable medical devices.