Title 21 Part 880 → Subpart F → §880.5450

Title 21 → Chapter I → Subchapter H → Part 880 → Subpart F → §880.5450

Electronic Code of Federal Regulations e-CFR

Title 21 Part 880 → Subpart F → §880.5450

e-CFR data is current as of May 29, 2020

Title 21Chapter ISubchapter HPart 880Subpart F → §880.5450

Title 21: Food and Drugs
Subpart F—General Hospital and Personal Use Therapeutic Devices

§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).