If the device has a port to connect to a mains oxygen gas supply or an oxygen gas cylinder it's likely that at least parts of the device will be enriched oxygen. Examples are incubators, ventilators, even humidifiers and CPAPs and anything that could be in the path of oxygen therapy.
"Enriched oxygen" sounds scary and might seem difficult to assess. But in fact you still need a combination of unlikely events to create a problem. The approach in the standard is quite reasonable and is based on making sure the specific combination of events cannot occur. Compliance can be achieved by common sense engineering, such routing the oxygen away from mains or high power parts, double seals and so on.