本文件规定: -在风险管理过程中，对医疗器械及其零部件或附件的气体通道进行生物评估的一般原则，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；-根据与气流接触的性质和持续时间，对气体通道进行一般分类评估所有来源的现有相关数据；-在风险分析的基础上确定可用数据集的差距确定分析气体通道生物安全性所需的其他数据集； -评估气体通道的生物安全性。 本文件涵盖了有关构成气体通道的医疗器械材料生物相容性评估的一般原则，但不包括任何机械故障引起的生物危害，除非该故障引入毒性风险（例如通过产生颗粒）。ISO 18562的其他部分包括针对添加到可吸入气流中的潜在危险物质的特定测试，并建立这些物质的验收标准。 本文件阐述了医疗器械内气体通道产生的气流可能受到的污染，这些气体可能随后被输送到患者身上。 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。交叉引用:ISO 7396-1:2016ISO 14971:2007ISO 10993-1:2009ISO 18562-3ISO 18562-2ISO 10993-17:2002ISO 18562-4ISO 10993-13ISO 10993-15BS 5724-3.12ISO 10993-14ISO 10993-9IEC 60601-1:2005IEC 17025A1:2012ISO 16142-1:2016ISO 13485:2016包含以下内容:勘误表，2020年2月

This document specifies: — the general principles governing the biological evaluation within a risk management process of 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 general categorization of gas pathways based on the nature and duration of their contact with the gas stream;— the evaluation of existing relevant data from all sources;— the identification of gaps in the available data set on the basis of a risk analysis;— the identification of additional data sets necessary to analyse the biological safety of the gas pathway;— the assessment of the biological safety of the gas pathway. This document covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, but does not cover biological hazards arising from any mechanical failure, unless the failure introduces a toxicity risk (e.g. by generating particulates). The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances. This document addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be 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 reprocessing.Cross References:ISO 7396-1:2016ISO 14971:2007ISO 10993-1:2009ISO 18562-3ISO 18562-2ISO 10993-17:2002ISO 18562-4ISO 10993-13ISO 10993-15BS 5724-3.12ISO 10993-14ISO 10993-9IEC 60601-1:2005IEC 17025A1:2012ISO 16142-1:2016ISO 13485:2016Incorporates the following:Corrigendum, February 2020