CGA V-1:2013

Standard Organization:

CGA V-1:2013
Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection

Recognition Date2014-07-09
Recognition List036
Recognition Number1-100
Extent Complete standard
Standards Orgs CGA Compressed Gas Associated, Incorporated https://www.cganet.com/
STG Anesthesiology
FDA Tech  James J. Lee   FDA/OMPT/CDRH/ODE/DAGID/RPDB/   301-796-8463   James.J.Lee@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

Detailed dimension drawings of 115 valve outlet connections for nearly 270 different products. Covers threaded connections yoke outlets and the Pin Index Safety System for flush outlet valves of the yoke type used for medical gases. The scope of this standard is to provide connections that minimize the possibility of hazardous misconnections. This standard is based on a coordinated plan for the inclusion of future connections as they are required on cylinders that are not permanently manifolded during transport and use. Standard outlet connections for respective gases are fully defined and complete in themselves. The outlet connections are designed to minimize the possibility of hazardous misconnections.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§868.2700 Regulator, Pressure, Gas Cylinder Class 1 CAN

FDA Guidance:

There is no relevant guidance developed at this time.


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