本文件规定了医疗器械、其零部件或附件的气体通道中颗粒物排放的测试，旨在为所有环境中的患者提供呼吸道护理或通过呼吸道供应物质。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。交叉引用: ISO 14971:2007 ISO 7396-1:2016ISO 18562-1:2017ISO 16000-37:2019BS ISO 16000-37:2019ISO 16142-1:2016ISO 10993ISO 7708:1995包含以下内容:勘误表，2020年2月

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 0,2 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.Cross References:ISO 14971:2007ISO 7396-1:2016ISO 18562-1:2017ISO 16000-37:2019BS ISO 16000-37:2019ISO 16142-1:2016ISO 10993ISO 7708:1995Incorporates the following:Corrigendum, February 2020