Medical oxygen concentrators produce gas in-situ. The concentrator is a certified medical device, and the oxygen purity is continuously measured. Medical oxygen generated by a hospital in this way for its own use requires no marketing authorisation.
For context, cryogenic air separation units (ASUs) produce oxygen which can be allocated to medical applications. In this case, the oxygen requires a marketing authorisation because the medical oxygen gas, not the oxygen generation equipment, is the subject of control.
These details, terminology and many more technical points related to production and quality control are covered in medical oxygen monographs. These documents form part of the US, European and Japanese Pharmacopeia and are akin to specifications or standards to produce medicinal gases.
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