21 CFR 878.5070
§ 878.5070 Air-handling apparatus for a surgical operating room.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.5070, § 878.5070 Air-handling apparatus for a surgical operating room, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90484
- Permanent ID
ys:prov:90484@1- SHA-256
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Full text
(a) Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.
(b) Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.