Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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014
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Date of Entry 03/31/2006
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FR Recognition Number
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1-67
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Standard | |
NFPA 99:2005 Standard for Health Care Facilities Chapter 20 - Hyperbaric Facilities |
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Scope/AbstractContinuing developments in medical equipment and processes create new opportunities for improved health care delivery, as well as new methods to mitigate fire, explosion, and electrical hazards. The 2005 NFPA 99: Health Care Facilities has been completely updated to present rules for the safe application of electrical systems, gas and vacuum systems, environment systems, materials and emergency management practices. |
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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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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§868.5470 |
Chamber, Hyperbaric |
Class 2 |
CBF |
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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. |