Standard Number: YY 9706.274-2022(YY9706.274-2022)
Chinese:医用电气设备 第2-74部分：呼吸湿化设备的基本安全和基本性能专用要求
English:Medical Electrical Equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
Effective Date:2025-05-01
ICS:11.040.10
Standard Applicability:This part specifies the basic safety and basic performance of humidifiers and their combinations with accessories. This part also applies to those accessories that the manufacturer anticipates can be used in conjunction with the humidifier and whose characteristics may affect the basic safety and basic performance of the humidifier. This part contains requirements for the use of the humidification function in various medical applications. This part also includes requirements for active HME (heat and moisture exchangers), i.e., ME devices that increase the humidity level of the gas delivered to the patient by HME through active heating and humidification. This part does not apply to passive HME, i.e., equipment that returns a portion of the patient’s exhaled moisture and heat to the respiratory tubing during the inspiratory phase without adding moisture or heat. This part does not specify requirements for cold reflux humidifier or bubble humidifier equipment. This part does not apply to humidifiers commonly referred to as “room humidifiers,” or humidifiers used in heating, ventilation, and air conditioning systems, or humidifiers integrated into infant incubators. This part does not apply to nebulizers that deliver medications to patients.
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