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U.S. Department of Health and Human Services

Recognized Consensus Standards

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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
Standard
ASME PVHO-1-2007
Safety Standard for Pressure Vessels for Human Occupancy
Scope/Abstract
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.5470 Chamber, Hyperbaric Class 2 CBF
FDA Technical Contact
 Nam To
  FDA/OC/CDRH/OPEQ/OHTI/DHTIC/
  301-796-4634
  Ka.To@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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