Respiratory tract humidifiers for medical use - Particular requirements for respiratory humidification systems (ISO 8185:2007, IDT)
This Malaysian Standard includes requirements for the basic safety and essential performance of humidification systems, as defined in 3.6. This standard 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). MS ISO 5367 specifies other safety and performance requirements for breathing tubes.
This standard 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. This standard 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. MS ISO 9360-1 and MS ISO 9360-2 specify safety and performance requirements for passive HMEs and descr
Published
• (none) / (none) / (none)
PDF
10/06/2019
64
NSC 18 - Medical Devices and Facilities for Healthcare
