21 C.F.R. § 880.5450

Current through November 30, 2024
Section 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).

21 C.F.R. § 880.5450