Patient care reverse isolation chamber.

21 C.F.R. § 880.5450
in effectEffective: 2024-07-01
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(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).

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