Standard Number: YY 9706.272-2021(YY9706.272-2021)
Chinese:医用电气设备 第2-72部分：依赖呼吸机患者使用的家用呼吸机的基本安全和基本性能专用要求
English:Medical electrical equipment Part2-72:Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
Effective Date:2024-05-01
ICS:11.040.10
Standard Applicability:This standard establishes the basic safety and essential performance of ventilators (hereinafter also referred to as ME devices) used in combination with accessories that are: intended for use in a home care setting; intended to be operated by inexperienced operators; and intended to be used to rely on the ventilator to support the patient’s life. The provisions of this standard also apply to accessories that are intended by the manufacturer to be used for connection to a VBS or for connection to a ventilator, and the characteristics of such accessories may affect the basic safety and basic performance of the ventilator. With the exception of 7.2.13 and 8.4.1 of GB 9706.1-2020, hazards resulting from the intended physiologic effects of ME equipment or ME systems within the scope of this standard are not specifically required in this standard. This standard does not apply to Continuous Positive Airway Pressure (CPAP) ME equipment, High Frequency Jet Ventilators (HFJV), and High Frequency Oscillatory Ventilators (HFOV). This standard does not apply to the requirements for iron armor and “iron lung” ventilators. This standard does not apply to the requirements of intensive care ventilators and their accessories. GB 9706.28 stipulates such requirements. This standard does not apply to anesthesia ventilators and their accessories requirements. gb 9706.29 provides such requirements. This standard does not apply to the requirements of emergency and transportation ventilators and their accessories, YY 0600.3 stipulates such requirements. This standard does not apply to the requirements of ventilators and their accessories for home care ventilation support equipment (expected to be used only to increase ventilation for spontaneously breathing patients), and YY 0600.1 stipulates such requirements. This standard does not apply to the requirements for ME equipment for the treatment of obstructive sleep apnea.YY 9706.270 (ISO 80601-2-70) specifies such requirements. This standard is a specialized standard in the GB 9706.1 series of standards.
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