| 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
|
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| FDA recognition of ASME PVHO-1-2007 [Rec# 1-78] will be superseded by recognition of ASME PVHO-1-2019 [Rec# 1-154].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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
