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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 014 Date of Entry 03/31/2006 
FR Recognition Number 1-67
Standard
NFPA 99:2005 Standard for Health Care Facilities Chapter 20 - Hyperbaric Facilities
Scope/Abstract
Continuing 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.
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
NFPA National Fire Protection Association http://www.nfpa.org/
FDA Specialty Task Group (STG)
Anesthesiology
*These are provided as examples and others may be applicable.
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