ISO 8185:2007是基于IEC 60601-1:1988及其修正案Amd的特定标准。 1:1991和Amd。 2:1995。 ISO 8185:2007包括对加湿系统的基本安全和基本性能的要求。它还包括为加湿系统（如加热呼吸管（加热丝呼吸管））和旨在控制这些加热呼吸管（加热呼吸管控制器）的设备使用的各个设备的要求。 ISO 5367规定了呼吸管的其他安全和性能要求。 注意加热呼吸管是医疗电气设备，符合IEC 60601-1的要求。 ISO 8185:2007还包括对活性HME（热和湿气交换器）装置的要求，其主动地加热和湿气以增加从HME输送到患者的气体的湿度水平。被动HME不适用于在吸入期间将患者过期的湿气和热量部分返回到呼吸道，而不增加热量和湿气。 ISO 9360-1和ISO 9360-2规定了被动HME的安全和性能要求，并描述了测试性能的方法。 呼吸道加湿器可以是气体供电的，电动的或两者兼有的。但是，ISO 8

ISO 8185:2007 is a particular standard based on IEC 60601-1:1988 and its Amendments, Amd. 1:1991 and Amd. 2:1995. ISO 8185:2007 includes requirements for the basic safety and essential performance of humidification systems. It also includes requirements for individual devices specified for use in humidification systems such as heated breathing tubes (heated-wire breathing tubes) and devices intended to control these heated breathing tubes (heated breathing tube controllers). ISO 5367 specifies other safety and performance requirements for breathing tubes. NOTE Heated breathing tubes are medical electrical equipment and are subject to the requirements of IEC 60601-1. ISO 8185:2007 also includes requirements for active HME (heat and moisture exchanger) devices, which actively add heat and moisture to increase the humidity level of the gas delivered from the HME to the patient. It is not applicable to passive HMEs, which return a portion of the patient's expired moisture and heat to the respiratory tract during inspiration without adding heat and moisture. ISO 9360-1 and ISO 9360-2 specify safety and performance requirements for passive HMEs and describe methods for testing performance. Respiratory tract humidifiers can be gas-powered, electrically-powered, or both. However, ISO 8185:2007 has been prepared as a particular standard based on IEC 60601-1, which gives general requirements for all aspects of safety, not only electrical safety, and many of the requirements are therefore applicable to humidifiers not powered by electricity. ISO 8185:2007 is not applicable to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators. ISO 8185:2007 is not applicable to nebulizers used for the delivery of drugs to patients.