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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 062 Date of Entry 05/29/2024 
FR Recognition Number 1-168
Standard
CGA  V-7.1:2021
Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
Scope/Abstract
This standard applies to the selection of an appropriate cylinder valve outlet connection for medical gases for pressures up to 3000 psi (20 680 kPa) at 70 °F (21.1 °C). It does not apply to industrial gas mixtures, cylinders manifolded in transport and use, or to mixtures at higher pressures. Both threaded and pin-indexed connection assignments are included with reference to CGA V-1, Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connections.

This revision replaces the use of limited standards with alternate standards for the purpose of assuring only one connection assignment will be appropriate. This revision brings consistency with ISO 407:2004, Small medical gas cylinders-Pin-index yoke-type valve connections, to standardize pin-indexed yoke-type valve connections globally.

The purpose of this standard is to establish a procedure for selecting the appropriate cylinder valve outlet connection for medical gases. It does not attempt to identify which medical gases may be safely manufactured nor indicate that the connection is safe or effective for any medical procedure. It is the responsibility of the manufacturer, the medical community, and appropriate regulatory bodies to make those decisions.
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FDA recognition of CGA V-7.1:2011 [Rec# 1-97] will be superseded by recognition of CGA V-7.1:2021 [Rec# 1-168]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-97] until July 5, 2026. After this transition period, declarations of conformity to [Rec# 1-97] 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
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  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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