Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (ISO 80601-2-72:2015)

2Scope / Description

This part of ISO 80601 specifies requirements for ventilators intended for home medical care for patients who depend on ventilation as a life-sustaining measure. These ventilators are often used in locations where the power supply for the ventilator is unreliable. These ventilators are often operated by non-medical personnel (non-professional operators) with varying levels of training. Ventilators that comply with this standard may also be used in other locations (i.e., in healthcare facilities). This part of ISO 80601 applies to the basic safety and essential performance characteristics of a ventilator in combination with its accessories, hereinafter referred to as the ME device, which is intended for use in home medical care. intended for use by a NON-PROFESSIONAL OPERATOR; intended for PATIENTS who depend on mechanical ventilation to sustain their lives. This part of ISO 80601 also applies to ACCESSORIES provided by the ACCESSORY MANUFACTURER for connection to a RESPIRATOR'S RESPIRATORY SYSTEM or to a RESPIRATOR, provided that the characteristics of this ACCESSORIES may affect the BASIC SAFETY or ESSENTIAL PERFORMANCE CHARACTERISTICS of the RESPIRATOR. This part of ISO 80601 does not apply to continuous positive airway pressure (CPAP) devices, high-frequency jet ventilators (HFJV), and high-frequency oscillatory ventilators (HFOV). This part of ISO 80601 does not specify requirements for body-enclosing and "iron lung" respirators. This part of ISO 80601 does not specify requirements for ventilators or their accessories for intensive care, which are contained in ISO 80601-2-12. This part of ISO 80601 does not specify requirements for ventilators...