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 an artificial ventilator. It is included in this discussion to highlight the differences, which indicate why sleep apnoea breathing therapy equipment is not considered a ventilator.
This document is intended to provide guidance that can assist manufacturers, authorities having jurisdiction and users in the development, selection and application of different types of ventilatory equipment based on the intended patient, intended use environment and intended operator.
[1] Numbers in square brackets refer to the Bibliography.
[2] Under preparation. Stage at the time of publication: ISO/FDIS 80601-2-12:2018.
[3] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2018.
