医疗保健应用中呼吸气体通路的生物相容性评估

[中文适用范围]： 注：条款 A.2 中包含了本条款的指导或原理。本文件规定了用于在所有环境中通过呼吸道为患者提供呼吸护理或供应物质的医疗器械及其部件或附件的气路中颗粒物排放的测试。本文件的测试旨在量化医疗器械及其部件或附件排放到可呼吸气流中的直径为 0.25 µm 至 10 µm 的颗粒。本文件为这些测试建立了验收标准。本文件不涉及纳米颗粒。没有足够的数据来为直径小于 0.25 µm 的颗粒建立暴露限值。本文件不涉及直径大于 10 µm 的颗粒。这些颗粒沉积在鼻腔中。可能需要有关绕过鼻腔的医疗器械或附件的其他信息。这超出了本文件的讨论范围，但某些主管部门可能会要求提供。因此，本文件采用与美国环境保护署 (EPA) 相同的方法，仅根据颗粒大小而不是其化学性质来设定限制。本文件解决了从气体通道中产生的气流的潜在污染，然后将其传导给患者。本文件适用于正常使用下的医疗器械的预期寿命，并考虑了任何预期处理的影响。本文件不涉及雾化器故意释放的颗粒 (即治疗剂) 的生物学评估。本文件不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可在 ISO 10993 系列中找到。包含本文件所述气体通路的医疗器械、部件或配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、氧气节流装置、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、医用呼吸个人防护设备、口器、复苏器、呼吸管、呼吸系统过滤器、 Y 型接头以及旨在与此类设备一起使用的任何呼吸配件。恒温箱的封闭腔体（包括床垫）和氧气罩的内表面被视为气体通路，也在本文件中涉及。本文件不涉及医疗器械正常使用时气源供应的气体中已经存在的污染。示例：ISO 18562（所有部分）并未涉及从气源（例如医用气体管道系统（包括管道出口的止回阀）、与医用气瓶连接或集成的压力调节器出口或进入医疗设备的室内空气）到达医疗设备的污染。1 [外文原描述]： This document specifies tests for the emissions of particulate matter 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 particles from 0,25 µm diameter to 10 µm diameter that are emitted by the medical device , its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests. This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,25 µm diameter . This document does not address particles larger than 10 µm diameter . These particles are deposited in the nasal cavity. Additional information can be needed for medical devices or accessories that bypass the nose. This is outside the scope of this document but can be required by some authorities having jurisdiction . This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry. This document addresses potential contamination of the gas stream arising from the gas pathways , which is then conducted to the patient . This document applies over the expected lifetime of the medical device in normal use and takes into account the effects of any intended processing . This document does not address biological evaluation of the particles that are deliberately released by a nebulizer (i.e. the therapeutic agent). This document does not address biological evaluation of the surfaces of gas pathways that have direct contact with the patient . The requirements for direct contact surfaces are found in the ISO 10993 series. 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, medical respiratory personal protective equipment, 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. This document 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 (all parts).