BS EN ISO 80601-2-80:2019

201.1   Scope, object and related standards IEC 60601‑1:2005+AMD1:2012, Clause 1, applies, except as follows:

201.1.1   * Scope

Replacement:

This document applies to the basic safety and essential performance of ventilatory support equipment , as defined in 201.3.205, for ventilatory insufficiency , as defined in 201.3.204, hereafter also referred to as me equipment , in combination with its accessories :

— intended for use in the home healthcare environment ;

— intended for use by a lay operator ;

— intended for use with patients who have ventilatory insufficiency or failure, the most fragile of which would likely experience injury with the loss of this artificial ventilation;

— intended for