Description

CGA E-18 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.

Product Details

Edition:

3rd

Published:

12/04/2019

Number of Pages:

30

File Size:

1 file , 1.3 MB

Description

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. Persons intending to manufacture, distribute,import, or sell medical devices as described by FDA and Health Canada shall adhere to all regulations.

Product Details

Edition:

2nd

Published:

03/01/2015

Number of Pages:

30

File Size:

1 file , 1.5 MB