ISO 18562-2:2017 医疗应用中呼吸气体通路的生物相容性评价 第2部分：颗粒物的排放测试

标准编号：ISO 18562-2:2017

中文名称：医疗应用中呼吸气体通路的生物相容性评价 第2部分：颗粒物的排放测试

英文名称：Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter

发布日期：2017-03

标准范围

ISO 18562-2:2017规定了医疗器械、其零部件或附件的气体通道中颗粒物排放的测试，旨在通过呼吸道向所有环境中的患者提供呼吸道护理或物质供应。本文件的测试旨在量化医疗器械、其零件或附件排放到可呼吸气流中的直径为0.2μm至10μm的颗粒。本文件确立了这些试验的验收标准。本文件不涉及纳米颗粒。没有足够的数据来确定直径小于0.2μm的颗粒的暴露极限。注1:更小和更大的颗粒也可能会造成生物危害，可能需要本文件范围之外的其他信息，以满足一些有管辖权的当局的要求。因此，ISO 18562-2:2017采用了与美国环境保护局（EPA）相同的方法，仅根据颗粒大小而非其化学性质设定限值。ISO 18562-2:2017解决了气体通道产生的气流潜在污染问题，然后将其输送至患者。ISO 18562-2:2017适用于正常使用中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 18562-2:2017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。包含本文件所述气体路径的医疗设备、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、氧气保存设备、氧气浓缩器、雾化器等-压力软管组件、加湿器、热湿交换器、呼吸气体监测仪、呼吸监测仪、面罩、口罩、复苏器、呼吸管、呼吸系统过滤器、Y形件以及拟与此类设备一起使用的任何呼吸附件。培养箱的封闭室（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 18562-2:2017未涉及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。例如，ISO 18562（所有部分）未涉及从气源（如医用气体管道系统（包括管道出口中的止回阀）、连接或集成到医用气瓶的压力调节器出口，或进入医疗设备的室内空气）到达医疗设备的污染。注2:本文件旨在阐述附件B中所示的相关安全和性能基本原则。

ISO 18562-2:2017 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 0,2 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 0,2 μm in diameter.NOTE 1 Smaller and larger particles could also present biological hazards, and additional information outside the scope of this document can be needed to meet requirements of some authorities having jurisdiction.ISO 18562-2:2017 therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.ISO 18562-2:2017 addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.ISO 18562-2:2017 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 18562-2:2017 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.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 18562-2:2017 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 (all parts).NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.

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