标准编号：ISO 5367:2014
中文名称：麻醉和呼吸设备 呼吸设备和连接器
英文名称：Anaesthetic and respiratory equipment — Breathing sets and connectors
发布日期：2014-10
标准范围
*This International Standard specifies basic requirements for breathing sets and breathing tubesintended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiersor nebulizers. It applies to breathing sets and breathing tubes and patient end adaptors suppliedalready assembled and to those supplied as components and assembled in accordance with themanufacturer’s instructions.This International Standard is applicable to breathing sets which include special components (e.g.water traps) between the patient end and machine end which are supplied already assembled.This International Standard is not applicable to breathing sets and breathing tubes for specialpurposes.EXAMPLE 1 Ventilators having special compliance, pressure or breathing frequency requirements.EXAMPLE 2 High Frequency Oscillatory Ventilation, (HFOV) or High Frequency Jet Ventilation (HFJV).EXAMPLE 3 Breathing sets and breathing tubes with special connectors for neonatal ventilation.Provision is made for coaxial and related bifurcated, double-lumen, or multiple-lumen breathing setsand breathing tubes suitable for use with patient end adaptors.NOTE 1 Examples of various types of breathing sets with patient end adaptors are depicted in Annex A.Requirements for exhalation valves, exhaust valves, adjustable pressure-limiting (APL) valves, heatand moisture exchangers (HMEs), breathing filters, and reservoir bags, if provided, are not covered bythis International Standard.NOTE 2 ISO 80601-2-12, ISO 80601-2-13, ISO 9360-1[3], ISO 23328-2[4], and ISO 5362[1] cover these.NOTE 3 Certain aspects of heated-wire breathing tubes are discussed in ISO 8185[2].
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