Biological Evaluation of Breathing Gas Pathways of Medical Devices, A New ISO Standard

With the recent development of ISO 18562, an important gap in the biological evaluation of medical devices has been addressed. ISO 10993, which covers biological evaluation of medical devices, does not sufficiently address the biological evaluation of the gas pathways of medical devices. ISO 18562 represents the application of the best-known science, in order to improve patient safety by addressing the risk of potentially hazardous substances being conveyed to the patient by the gas stream. There are three main risks to patient safety when it comes to breathing gas pathways of medical devices, emission of particulate matter into the gas stream, emission of volatile organic compounds into the gas stream, and substances leached by liquid water condensing into gas pathways of medical devices. In this presentation, we will discuss what this new standard entails and the methods used to meet the testing needs outlined in ISO 18562.