ISO 18562-2:2024 卫生保健应用中呼吸气体通路的生物相容性评价 第2部分：颗粒物的排放试验

标准编号：ISO 18562-2:2024

中文名称：卫生保健应用中呼吸气体通路的生物相容性评价 第2部分：颗粒物的排放试验

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：2024-03

标准范围

本文件规定了医疗器械、其部件或附件的气体通道中颗粒物排放的测试，这些器械旨在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。本文档的测试旨在量化0,25？μ m直径至10？由医疗设备、其部件或附件排放到可呼吸气流中的直径为μ m的气体。本文件建立了这些试验的验收标准。该文件不涉及纳米颗粒。没有足够的数据来确定小于0,25的微粒的接触限值？μ m直径。本文件不涉及大于10的颗粒？μ m直径。这些颗粒沉积在鼻腔中。对于绕过鼻子的医疗设备或附件，可能需要额外的信息。这超出了本文档的范围，但一些有管辖权的机构可能会要求这样做。因此，本文件采用了与美国环境保护局(EPA)相同的方法，仅根据颗粒尺寸而不是其化学性质来设定限值。该文件解决了由气体路径产生的气流的潜在污染，然后将其传导至患者。本文件适用于医疗器械正常使用的预期寿命，并考虑了任何预期处理的影响。本文件不涉及喷雾器故意释放的颗粒（即治疗剂）的生物学评价。本文件未涉及与患者直接接触的气体通道表面的生物学评价。直接接触面的要求见ISO？10993系列。本文所述的包含气体路径的医疗装置、部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、热和湿交换器、呼吸气体监测器、呼吸监测器、面罩、医疗呼吸个人防护设备、嘴件、复苏器、呼吸管、呼吸系统过滤器、Y形件以及旨在与此类装置一起使用的任何呼吸附件。培养箱的封闭腔室（包括床垫）和氧气罩的内表面被认为是气体通道，并且也由本文件解决。本文件不涉及医疗器械正常使用时从气体源供应的气体中已经存在的污染。例子？来自气体源（如医用气体管道系统（包括管道出口中的止回阀）、与医用气体钢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物未被ISO处理？18562（所有零件）。

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).

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