scope:

This publication applies to cylinder gas-pressure regulators; pressure regulators with integrated flowmeter devices; medical gas flowmetering devices (flowmeters); pressure regulator/flowmeter and pressure regulator/ flowgauge combinations; and orifice flow selectors used in the administration of medical gases for treatment, management, diagnostic evaluation, and care of patients. A pressure regulator and flowmeter used in combination shall meet the minimum requirements for each device.

Devices described in this document shall be compliant with the U.S. Food and Drug Administration (FDA) requirements described in Title 21 of the U.S. Code of Federal Regulations (21 CFR) [1].¹ Persons intending to manufacture, distribute, assemble, import, or sell medical devices as described by FDA shall adhere to all required regulations.

This publication does not apply to pressure regulators or flowmeters used as a permanent part of a piped medical gas distribution system; pressure regulators or flowmeters used as an integral part of medical equipment, vacuum regulators, demand valves or gas mixers; cylinder valve-integrated pressure regulators; or electrical or electronic regulators or flowmeters.

For the purpose of this publication, the use of the term device(s) includes pressure regulators, flowmeters, and orifice flow selectors.