[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR880.5450]

[Page 384]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES--Table of Contents
 
    Subpart F--General Hospital and Personal Use Therapeutic Devices
 
Sec. 880.5450  Patient care reverse isolation chamber.

    (a) Identification. A patient care reverse isolation chamber is a 
device consisting of a roomlike enclosure designed to prevent the entry 
of harmful airborne material. This device protects a patient who is 
undergoing treatment for burns or is lacking a normal immunosuppressive 
defense due to therapy or congenital abnormality. The device includes 
fans and air filters which maintain an atmosphere of clean air at a 
pressure greater than the air pressure outside the enclosure.
    (b) Classification. Class II (performance standards).