---
kind: "section"
citation: "21 C.F.R. § 868.5935"
title: "21"
number: "868.5935"
heading: "External negative pressure ventilator."
url: "https://uscodex.org/cfr/21/868.5935"
---

# §868.5935. External negative pressure ventilator.

- (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).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 47 FR 31142, July 16, 1982, unless otherwise noted.