NF EN ISO 80601-2-12

Le présent document s'applique aux ventilateurs de soins intensifs. Ce document donne les prescriptions complémentaires à celles de sécurité de la norme générale NF EN 60601-1:1990 sur les appareils électromédicaux. Il donne les moyens de se conformer aux exigences des Directives "Dispositifs médicaux" 93/42/CE et "Machines" 2006/42/CE.

Le présent document spécifie les exigences de sécurité des VENTILATEURS, destinés à être utilisés dans les unités de soins intensifs. Ce document entre dans le champ d'application de la Directive n° 93/42/CEE du 14/06/1993 relative aux dispositifs médicaux.

<p>This document applies to the <i>basic safety</i> and <i>essential performance</i> of a <i>ventilator</i> in combination with its <i>accessories</i>, hereafter referred to as <i>ME equipment:</i> </p> <ul> <li> intended for use in an environment that provides specialized care for <i>patients</i> whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a <i>professional healthcare facility;</i> </li> </ul> <p>NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. <i>Ventilators</i> for this environment are considered life-sustaining. </p> <p>NOTE 2 For the purposes of this document, such a <i>ventilator</i> can provide transport within a <i>professional healthcare facility</i> (i.e. be a <i>transit-operable</i> <i>ventilator</i>). </p> <p>NOTE 3 A critical care <i>ventilator</i> intended for use in transport within a <i>professional healthcare facility</i> is not considered as an <i>emergency medical services environment</i> <i>ventilator</i>.</p> <ul> <li> intended to be operated by a <i>healthcare professional</i> <i>operator</i>; and </li> <li> intended for those <i>patients</i> who need differing levels of support from artificial ventilation including for <i>ventilator-dependent patients</i>. </li> </ul> <p>A critical care <i>ventilator</i> is not considered to utilize a <i>physiologic closed-loop-control system</i> unless it uses a physiological <i>patient</i> variable to adjust the ventilation therapy settings.</p> <p>This document is also applicable to those <i>accessories</i> intended by their <i>manufacturer</i> to be connected to a <i>ventilator breathing system</i>, or to a <i>ventilator</i>, where the characteristics of those <i>accessories</i> can affect the <i>basic safety</i> or <i>essential performance</i> of the <i>ventilator</i>. </p> <p>NOTE 4 If a clause or subclause is specifically intended to be applicable to <i>ME equipment</i> only, or to <i>ME systems</i> 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 <i>ME equipment</i> and to <i>ME systems</i>, as relevant.</p> <p><i>Hazards</i> inherent in the intended physiological function of <i>ME equipment</i> or <i>ME systems</i> 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.</p> <p>NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.</p> <p>This document is not applicable to <i>ME equipment</i> or an <i>ME system</i> operating in a <i>ventilator-operational mode</i> solely intended for <i>patients</i> who are not dependent on artificial ventilation. </p> <p>NOTE 6 A critical care <i>ventilator</i>, when operating in such a <i>ventilator-operational mode</i>, is not considered life-sustaining<i>.</i></p> <p>This document is not applicable to <i>ME equipment</i> that is intended solely to augment the ventilation of spontaneously breathing <i>patients</i> within a <i>professional healthcare facility</i>. </p> <p>This document does not specify the requirements for: </p> <ul> <li> <i>ventilators</i> or <i>accessories</i> intended for anaesthetic applications, which are given in ISO 80601-2-13^[2];</li> <li> <i>ventilators</i> or <i>accessories</i> intended for the <i>emergency medical services environment</i>, which are given in ISO 80601-2-84^[3], the future replacement for ISO 10651-3^[4]; </li> <li> <i>ventilators</i> or <i>accessories</i> intended for <i>ventilator-dependent</i> <i>patients </i>in the <i>home healthcare environment</i><i>,</i> which are given in ISO 80601‑2-72:2015^[5]; </li> <li> <i>ventilators</i> or <i>accessories</i> intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018^[6] and ISO 80601-2-80:2018^[7]^{^[1]}; </li> <li> obstructive sleep apnoea therapy <i>ME equipment</i>, which are given in ISO 80601‑2‑70^[9]; </li> <li> <i>continuous</i><i> positive airway pressure</i> (<i>CPAP</i>) <i>ME equipment;</i></li> <li> high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87^[63]; </li> </ul> <p>NOTE 7 A critical care <i>ventilator</i> can incorporate high-frequency jet or high-frequency oscillatory <i>ventilator-operational mode</i><i>s</i>.</p> <ul> <li> oxygen therapy constant flow <i>ME equipment</i>; and</li> <li> cuirass or "iron-lung" ventilation equipment. </li> </ul> <p>[1] ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.</p>