Medical air reconstituted from oxygen USP and nitrogen NF should meet all of the following requirements except?

The requirement concerning medical air reconstituted from oxygen USP and nitrogen NF specifies the necessary standards for safety, purity, and regulatory compliance. Among the listed requirements, the one that is not necessary involves the completion of a risk analysis and approval by the authority having jurisdiction before use.

Typically, the production of medical air must adhere to stringent guidelines, which include specific oxygen concentration levels, continuous monitoring of gas analysis, and proper FDA approval for marketing. The acceptable range for oxygen concentration is specifically set between 19.5% to 23.5%. Continuous analysis and recording ensure that the air quality remains within these defined parameters to guarantee patient safety.

While risk analysis is an essential component of any medical product use, it is not a direct requirement dictated by the standard production protocols for medical air as outlined in the standards and regulations. Instead, completion of a risk analysis is typically part of a broader safety management strategy but does not negate compliance with existing regulatory standards mandated for medical air production and usage.