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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 036 Date of Entry 07/09/2014 
FR Recognition Number 1-100
Standard
CGA  V-1:2013
Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of CGA V-1:2013 [Rec# 1-100] will be superseded by recognition of CGA V-1:2021 [Rec# 1-169]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-100] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 1-100] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.2700 Regulator, Pressure, Gas Cylinder Class 1 CAN
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Benjamin Sommerkorn
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  240-402-8542
  Benjamin.Sommerkorn@fda.hhs.gov
Standards Development Organization
CGA Compressed Gas Associated, Incorporated https://www.cganet.com/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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