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 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.
Le présent document révise les exigences pour le reflux de gaz entre orifices d'entrée haute pression.
<p>ISO 80601-2-12:2011 applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as me equipment: </p> <ul> <li>intended to be attended by a professional operator for those patients who are dependent on mechanical ventilation; and </li> <li>intended for use in critical care environments in a professional healthcare facility or intended for use in transport within a professional healthcare facility. </li> </ul> <p>ISO 80601-2-12:2011 is also applicable to those accessories intended by their manufacturer to be connected to a breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator. </p> <p>ISO 80601-2-12:2011 is not applicable to me equipment or an me system operating in ventilation modes intended for patients who are not dependent on mechanical ventilation. </p> <p>ISO 80601-2-12:2011 is not applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation. </p> <p>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.</p> <p>ISO 80601-2-12:2011 is not applicable to continuous positive airway pressure (CPAP) me equipment, sleep apnoea therapy me equipment, home healthcare environment ventilators, ventilatory support me equipment, emergency and transport ventilators, anaesthetic ventilators, high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs). ISO 80601-2-12:2011 does not specify the requirements for me equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility. </p> <p>ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for anaesthetic applications which are given in ISO 80601-2-13. </p> <p>ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients which are given in ISO 10651-2. </p> <p>ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for emergency and transport which are given in ISO 10651-3. </p> <p>ISO 80601-2-12:2011 does not specify the requirements for ventilators or accessories intended for home-care ventilatory support devices which are given in ISO 10651-6. </p>
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