part_subject: "GENERAL HOSPITAL AND PERSONAL USE DEVICES"
subpart_code: "F"
subpart_subject: "General Hospital and Personal Use Therapeutic Devices"
section_number: "880.5450"
section_subject: "Patient care reverse isolation chamber."
cfr_reference: "21 CFR 880.5450"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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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).