本文件规定了通过液态水冷凝到医疗设备、其零件或附件的气体通道中，以提供呼吸道护理或通过呼吸道向所有环境中的患者提供物质的物质浸出试验。本文件的测试旨在量化危险的水溶性物质，这些物质通过冷凝水从医疗器械、其零件或附件中渗出，然后通过该液体输送给患者。本文件确立了这些试验的验收标准。 本文件阐述了气体通道产生的气流的潜在污染，然后将其输送至患者。 本文件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交叉参考:ISO 7396-1:2016ISO 10993-5ISO 18562- 1:2017ISO 14971:2007ISO 10993-1ISO 10993-10ISO 10993-12:2012ISO 10993-18TS 10993-19ISO 10993-11ISO 10993-9ISO 10993-17ISO 10993-15TS 10993-20ISO 10993-4ISO 10993-16ISO 10993-13ISO 10993-6ISO 10993-3ISO 10993-2ISO 10993-14ISO 16142-1:2016ISO 10993-7包含以下内容:勘误表，2020年2月

This document specifies tests for substances leached by liquid water condensing into 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 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. This document establishes acceptance criteria for these tests. 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 SERVICE LIFE of the MEDICAL DEVICE in NORMAL USE and takes into account the effects of any intended processing or reprocessingCross References:ISO 7396-1:2016ISO 10993-5ISO 18562-1:2017ISO 14971:2007ISO 10993-1ISO 10993-10ISO 10993-12:2012ISO 10993-18TS 10993-19ISO 10993-11ISO 10993-9ISO 10993-17ISO 10993-15TS 10993-20ISO 10993-4ISO 10993-16ISO 10993-13ISO 10993-6ISO 10993-3ISO 10993-2ISO 10993-14ISO 16142-1:2016ISO 10993-7Incorporates the following:Corrigendum, February 2020