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47 FR 31142, July 16, 1982, unless otherwise noted.
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Subscribe to: 21 CFR 868.5935
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Nomenclature changes to part 868 appear at 73 FR 35341, June 23, 2008.
(a) Identification. An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.
(b) Classification. Class II (performance standards).