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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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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
NFPA  99:2005
Standard for Health Care Facilities Chapter 20 - Hyperbaric Facilities
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.
Transition Period
FDA recognition of NFPA 99:2005 [Rec# 1-67] will be superseded by recognition of NFPA 99:2021 [Rec# 1-153]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 1-67] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 1-67] 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
 Annie Abraham
Standards Development Organization
NFPA National Fire Protection Association http://www.nfpa.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.