ISO 18562-3:2017规定了医疗设备、其部件或附件的气体通道中挥发性有机化合物（vocs）排放的测试，这些气体通道用于在所有环境中为患者提供呼吸护理或通过呼吸道供应物质。本文件的测试旨在量化气体通道材料添加到可吸入气流中的挥发性有机物的排放量。本文件确定了这些测试的验收标准。 ISO 18562-3: 2017年解决了气体路径产生的气流的潜在污染，然后将其输送至患者。 ISO 18562-3:2017适用于正常使用的医疗器械的预期使用寿命，并考虑了任何预期加工或再加工的影响。 ISO 18562-3:2017未涉及与患者直接接触的气体通道表面的生物学评估。直接接触表面的要求见ISO 10993系列[1]。 本文件涉及的包含气体通道的医疗设备、零件或附件包括但不限于呼吸机、麻醉工作站（包括气体混合器）、呼吸系统、氧气保存装置、氧气浓缩器、雾化器、低压软管组件、加湿器、热湿交换器、呼吸气体监测器、呼吸监测器、面罩、，口罩、复苏器、呼吸管、呼吸系统过滤器、Y形件和任何拟与此类设备一起使用的呼吸附件。 保温箱的封闭室（包括床垫）和氧气罩的内表面被视为气体通道，本文件也对其进行了说明。 ISO 18562-3:2017没有解决医疗设备正常使用时，从气源供应的气体中已经存在的污染问题。 示例:ISO 18562系列未解决从气源（如医用气体管道系统（包括管道出口中的止回阀）、与医用气瓶连接或集成的压力调节器出口或吸入医疗器械的室内空气）到达医疗器械的污染。 ISO 18562-3:2017旨在与ISO 18562-1一起阅读。 注:本文件旨在阐述附件B所示的安全和性能的相关基本原则。

ISO 18562-3:2017 specifies tests for the emissions of volatile organic compounds (vocs) from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify emissions of vocs that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests. ISO 18562-3:2017 addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient. ISO 18562-3:2017 applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing. ISO 18562-3:2017 does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series[1]. Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document. ISO 18562-3:2017 does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use. EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 series. ISO 18562-3:2017 is intended to be read in conjunction with ISO 18562‑1. NOTE This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.