The Importance of Biocompatibility Testing of Breathing Gas Pathways in Medical Devices
Medical practitioners use respiratory and ventilation devices to assist in the diagnosis, monitoring and treatment of respiratory issues, as well as to deliver anesthesia and gas-borne medications.
These devices may pose unique risks to patients’ health and safety. Testing in accordance with the technical requirements of the ISO 18562 series of standards helps mitigate these risks. While demonstrating compliance can be complex, UL Solutions can help manufacturers navigate this process.
This UL Solutions white paper discusses the importance of biocompatibility testing of breathing gas pathways in medical devices and how testing in accordance with the technical requirements of the ISO 18562 series of standards can strengthen claims of biocompatibility in support of FDA 510(k) submissions.
Beginning with a brief review of the FDA’s clearance process for medical devices and the timelines for the agency’s review of 510(k) submissions, the paper then discusses the specific biocompatibility challenges associated with medical devices that include breathing gas pathways.
Our white paper includes insights on the benefits of a preventive and proactive approach to assessing and testing the biocompatibility of gas pathways in medical devices.
ISO 18562 VOC and Particle Testing for Respiratory Devices
Start with necessary testing and compliance assistance in advance to help navigate the information required for U.S. FDA 510(k) clearance.