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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 059 Date of Entry 12/19/2022 
FR Recognition Number 1-153
NFPA  99:2021
Health Care Facilities Code
1.1.1 The scope of this code is to establish minimum criteria as follows in 1.1.2 through 1.1.13.

1.1.2 Fundamentals. Chapter 4 establishes criteria for levels of health care services or systems based on risk to the patients, staff, or visitors in health care facilities.

1.1.3 Gas and Vacuum Systems. Chapter 5 covers the performance, maintenance, installation, and testing of the following: (1) Nonflammable medical gas systems with operating pressures below a gauge pressure of 2068 kPa (300 psi) (2) Vacuum systems in health care facilities (3) Waste anesthetic gas disposal (WAGD) systems, also referred to as scavenging (4) Manufactured assemblies that are intended for connection to the medical gas, vacuum, or WAGD systems (also referred to as scavenging) Requirements for portable compressed gas systems are covered in Chapter 11.

1.1.4 Electrical Systems. Chapter 6 covers the performance, maintenance, and testing of electrical systems (both normal and essential) in health care facilities. The following areas are not addressed in this code, but are addressed in other NFPA documents: (1) Specific requirements for wiring and installation of equipment are covered in NFPA 70, National Electrical Code. (2) Requirements for illumination and identification of means of egress in health care facilities are covered in NFPA 101, Life Safety Code. (3) Requirements for installation, testing, and maintenance of fire protection signaling systems are covered in NFPA 72, National Fire Alarm and Signaling Code. (4) Requirements for installation of fire pumps are covered in NFPA 20, Standard for the Installation of Stationary Pumps for Fire Protection, except that the alternate source of power are permitted to be the essential electrical system. (5) Requirements for installation of stationary engines and gas turbines are covered in NFPA 37, Standard for the Installation and Use of Stationary Combustion Engines and Gas Turbines.
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.