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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 059 Date of Entry 12/19/2022 
FR Recognition Number 1-154
Standard
ASME  PVHO-1-2019
Safety Standard for Pressure Vessels for Human Occupancy
Scope/Abstract
This Standard provides requirements for the design, fabrication, inspection, testing, marking, and stamping of pressure vessels for human occupancy, having an internal or external pressure differential exceeding 2 psi. This Standard also provides requirements for the design, fabrication, inspection, testing, cleaning, and certification of piping systems for PVHOs. A PVHO is a pressure vessel that encloses a human being within its pressure boundary while it is under internal or external pressure that exceeds a 2 psi differential pressure. PVHOs include, but are not limited to, submersibles, diving bells, personnel transfer capsules, decompression chambers, recompression chambers, hyperbaric chambers, high altitude chambers, and medical hyperbaric oxygenation facilities. This does not include nuclear reactor containments, pressurized airplane and aerospace vehicle cabins, and caissons.
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
§868.5470 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
  FDA/OMPT/CDRH/OPEQ/OHTI/DHTIC
  240-402-5219
  Annie.Abraham@fda.hhs.gov
Standards Development Organization
ASME American Society of Mechanical Engineers https://www.asme.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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