21 CFR 880.5450
§ 880.5450 Patient care reverse isolation chamber.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 880.5450, § 880.5450 Patient care reverse isolation chamber, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90540
- Permanent ID
ys:prov:90540@1- SHA-256
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Full text
(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).
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.