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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 034 Date of Entry 01/30/2014 
FR Recognition Number 1-81
Standard
CGA  V-5:2008 (Reaffirmed 2013)
Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
Scope/Abstract
Provides dimensions and other data to produce or use medical designed fittings for various gas connections used in hospital or patient care applications. The fittings are gas specific and noninterchangeable. This will avoid cross-connection of medical gases.
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.
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
§868.5160 Gas-Machine, Anesthesia Class 2 BSZ
§868.5925 Ventilator, Emergency, Powered (Resuscitator) Class 2 BTL
Relevant FDA Guidance and/or Supportive Publications*
Draft Emergency Resuscitator Guidance, April 1993

Draft Reviewer Guidance for Ventilators, July 1995

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
 Jennifer E. Danieley
  FDA/OC/CDRH/OPEQ/OHTII/DHTIIA/
  301-796-0309
  jennifer.danieley@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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