Guidance on the selection of the appropriate means of ventilation based on the intended patient, use environment, and operator

ISO TR 21954:2018 This document considers and identifies criteria about the intended patient, intended use environment, and intended operator across the spectrum of the types of ventilation-related equipment as listed below:

— gas-powered resuscitator as specified in ISO 10651-5[1] [1];

— operator-powered resuscitator as specified in ISO 10651-4[2];

— ventilator for critical care as specified in ISO 80601-2-12[3] [2];

— ventilator for emergency medical services environment as specified in ISO 80601-2-84[4] [3], the future replacement for ISO 10651-3[5];

NOTE 1 ISO 80601‐2‐84 updates the content of ISO 10651‐3 and harmonizes it with IEC 60601-1:2005+AMD1:2012[6] and IEC 60601-1-12:2014[7].

— ventilator for ventilatory impairment in the home healthcare environment as specified in ISO 80601？2？79[8];

— ventilator for ventilatory insufficiency in the home healthcare environment as specified in ISO 80601？2？80[9];

— ventilator for ventilator-dependent patients in the home healthcare environment as specified in ISO 80601-2-72[10];

— sleep apnoea breathing therapy equipment as specified in ISO 80601-2-70[11].

NOTE 2 Sleep apnoea breathing therapy equipment is not considered to be