Scope
Replacement:
This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment:
? intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;
NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. High-frequency ventilators for this environment are considered life-sustaining.
NOTE 2 For the purposes of this document, such a high-frequency ventilator can provide transport within a professional healthcare facility (i.e., be a transit-operable ventilator).
NOTE 3 A high-frequency ventilator intended for use in transport within a professional healthcare facility is not considered as a ventilator intended for the emergency medical services environment.
? intended to be operated by a healthcare professional operator;
? intended for those patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; and
? capable of providing more than 150 inflations/min.
There are three principal designations of HFV:
? high-frequency percussive ventilation [HFPV, with a typical HFV frequency of (60 to 1 000) HFV inflations/min];
? high-frequency jet ventilation [HFJV, with a typical HFV frequency of (100 to 1 500) HFV inflations/min]; and
? high-frequency oscillatory ventilation [HFOV, with a typical HFV frequency of (180 to 1200) HFV inflations/min and typically having an active expiratory phase].
? respiratory high-flow ME equipment, which are given in ISO 80601-2-90:—1; and
? cuirass or “iron-lung” ventilation equipment.
This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.