NFPA 99:2005

Standard Organization:

NFPA 99:2005
Standard for Health Care Facilities Chapter 20 - Hyperbaric Facilities

Recognition Date2006-03-31
Recognition List014
Recognition Number1-67
Extent Complete standard
Standards Orgs NFPA National Fire Protection Association http://www.nfpa.org/
STG Anesthesiology
FDA Tech  Nam To   FDA/OMPT/CDRH/ODE/DAGID/ANDB/   301-796-4634   Ka.To@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§868.5470 Chamber, Hyperbaric Class 2 CBF

FDA Guidance:

There is no relevant guidance developed at this time.


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