ISO 18562-4:2024 卫生保健应用中呼吸气体通路的生物相容性评价 第4部分：冷凝物中析出物的试验

标准编号：ISO 18562-4:2024

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4部分：冷凝物中析出物的试验

英文名称：Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 4: Tests for leachables in condensate

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液态水冷凝而浸出的物质的测试，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。本文件中描述的化学表征方法适用于可能从医疗器械、其部件或附件浸出到冷凝液中的化学物质。本文件建立了这些试验的可验证验收标准。释放的每种化学品的特性和数量旨在用于毒理学风险评估，如ISO？18562-1:2024.该文件解决了由向患者输送呼吸气体的气体路径产生的气流的潜在污染。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形件和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？从诸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等气体源到达医疗器械的污染物。本文件不涉及与药物或麻醉剂的接触。如果医疗器械或附件打算与麻醉剂或药物一起使用，则可能需要额外的测试。本文件旨在量化通过冷凝液从医疗器械、其部件或附件中浸出，然后通过该液体输送给患者的有害水溶性物质。

This document specifies tests for substances leached by liquid water condensing in 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 chemical characterization methods described in this document apply to chemical substances that could leach from the medical device, its parts or accessories into the condensate. This document establishes verifiable acceptance criteria for these tests. The identity and quantity of each chemical released is intended for toxicological risk assessment as described in ISO 18562-1:2024.

This document addresses potential contamination of the gas stream arising from the gas pathways, which deliver breathing gas 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 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.

This document does not address contact with drugs or anaesthetic agents. If a medical device or accessory is intended to be used with anaesthetic agents or drugs, then additional testing can be required. This document is intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient.

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