BS EN ISO 80601-2-84:2023 PDF

201.1   Scope, object and related standards

IEC 60601‑1:2005+AMD1:2012+AMD2:2020 , Clause 1 applies, except as follows:

201.1.1   Scope

Replacement:

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.

This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories , hereafter also referred to as ME equipment:

— intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients ;

— intended to be operated by a healthcare professional operator ;

— intended for use in the EMS environment ; and

— intended for invasive or non-invasive