This standard applies to medical gas valve integrated pressure regulators (VIPRs) that are mounted on refillable cylinders use in the administration of medical gases for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in humans or other animals. VIPRs covered by this standard are pressure preset and provided with a pressure outlet and/ or preset flow outlets.
Devices described in this standard shall comply with the U.S. FDA requirements in 21 CFR, and the Health Canada requirements described in the Medical Devices Regulations. Persons intending to design, manufacture, distribute, import, or sell medical devices as described by FDA and Health Canada shall comply to all regulations.
This publication does not address any personnel safety or health concerns, nor does it address any environmental requirements, which may be involved in the testing or manufacture of these devices.