Appareils électromédicaux - Partie 2-84: Exigences particulières pour la sécurité de base et les performances essentielles des ventilateurs de secours et de transport

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 for VENTILATOR-DEPENDENT PATIENTS;

-              for use in the EMS ENVIRONMENT; and

-              For invasive or non-invasive ventilation.

NOTE 1 An EMS VENTILATOR can also be used for transport within a PROFESSIONAL HEALTHCARE FACILITIES.

This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to a BREATHING SYSTEM of an EMS VENTILATOR, or to an EMS VENTILATOR, where the characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the EMS VENTILATOR.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.

NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

This part of ISO 80601 does not specify the requirements for

-              VENTILATORS or ACCESSORIES intended for VENTILATOR-DEPENDENT PATIENTS in critical care applications, which are given in ISO 80601-2-12 [3].

-              VENTILATORS or ACCESSORIES intended for VENTILATOR-DEPENDENT PATIENTS in the HOME HEALTHCARE ENVIRONMENT, which are given in ISO 80601-2-72 [4].

-              VENTILATORS or ACCESSORIES intended for anaesthetic applications, which are given in ISO 80601-2-13 [5].

-              VENTILATORS or ACCESSORIES intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing PATIENTS), which are given in ISO 80601-2-79 [6] and ISO 80601-2-80 [7].

-              Obstructive sleep apnoea therapy ME EQUIPMENT, which are given in ISO 219 80601-2-70 [8].

-              OPERATOR-powered resuscitators, which are given in ISO 10651-4 [9].

-              Gas-powered emergency resuscitators, which are given in ISO 10651-5 [10].

-              Continuous positive AIRWAY PRESSURE (CPAP) ME EQUIPMENT.

-              High-frequency jet VENTILATORS (HFJVs).

-              High-frequency oscillatory VENTILATORS (HFOVs) [11].

-              Cuirass or “iron-lung” VENTILATORS.

This part of ISO 80601 is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of documents.