ISO 18562 provides standards for evaluating the biocompatibility risks associated with the gas pathway of medical devices for respiratory care. The tests associated with the 18562 series assess risks that are related to the volatile organic compounds (VOCs), particulates, and leachables in condensate that have potential to be emitted or leached from the device during its intended use. Anything that may be emitted during use may ultimately have contact with the patients or end users, and the Toxicological Risk Assessment (TRA) then assesses the risks.
You can expect to learn the following from this webinar:
- Various test methods associated with ISO 18562
- Interpretation of results
- Risk identification
- Possible risk mitigation