Applicable to low-pressure regulators suitable for inlet pressures between 280 kPa and 600 kPa, supplied and packaged for use in medical equipment intended for the administration of medical gases in the management, treatment, diagnostic evaluation and patient care for use of the following medical gases; xenon, helium, carbon dioxide, nitrous oxide, oxygen, air for breathing, and specified mixtures of the listed gases. Not applicable to pressure regulators supplied as spare parts for a specific application, or used for those with suction services.