BS EN ISO 8185:2009 Respiratory tract humidifiers for medical use. Particular requirements for respiratory humidification systems
BS EN ISO 8185 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). BS 6151:1992 specifies other safety and performance requirements for breathing tubes.
BS EN ISO 8185 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. BS EN ISO 8185 does not apply 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, BS EN ISO 8185 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. Where BS EN ISO 8185 specifies that a clause of IEC 60601-1 applies, it means that the Clause applies only if the requirement is relevant to the humidification system under consideration.
BS EN ISO 8185 does not apply to devices commonly referred to as "room humidifiers" or humidifiers used in heating, ventilation and air conditioning systems, or humidifiers incorporated into infant incubators.
BS EN ISO 8185 does not apply to nebulizers used for th...
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