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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 1-78
ASME  PVHO-1-2007
Safety Standard for Pressure Vessels for Human Occupancy
This Standard applies to all pressure vessels that enclose a human within its pressure boundary while under internal or external pressure exceeding a differential pressure of 2 psi. PVHOs include, but are not limited to, submersibles, diving bells, personnel transfer capsules; and decompression, recompression, hypobaric, and hyperbaric PVHOs.
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FDA recognition of ASME PVHO-1-2007 [Rec# 1-78] will be superseded by recognition of ASME PVHO-1-2019 [Rec# 1-154]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-78] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 1-78] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.5470 Chamber, Hyperbaric Class 2 CBF
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
 Annie Abraham
Standards Development Organization
ASME American Society of Mechanical Engineers https://www.asme.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.