Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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059
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Date of Entry 12/19/2022
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FR Recognition Number
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1-154
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Standard | |
ASME PVHO-1-2019 Safety Standard for Pressure Vessels for Human Occupancy |
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Scope/AbstractThis 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. |
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Extent of Recognition
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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. |
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Transition Period
FDA recognition of ASME PVHO-1-2019 [Rec# 1-154] will be superseded by recognition of ASME PVHO-1-2023 [Rec# 1-181]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-154] until December 26, 2026. After this transition period, declarations of conformity to [Rec# 1-154] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§868.5470 |
Chamber, Hyperbaric
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Class 2
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CBF
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |