This publication applies to medical gas VIPRs used 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.
Devices described in this publication are 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), and the Health Canada requirements described in the Medical Devices Regulations.1 Persons intending to manufacture, distribute, import, or sell medical devices as described by FDA and Health Canada shall adhere to all regulations.