BS ISO 18562-1:2017规定:风险管理过程中生物评估的一般原则: 医疗设备、其零件或附件的气体通道，旨在提供 呼吸道护理或通过呼吸道向所有环境中的患者供应物质；根据气体通道与环境接触的性质和持续时间，对气体通道进行一般分类 气流；评估所有来源的现有相关数据；根据风险分析确定可用数据集中的差距； 确定分析气体生物安全性所需的其他数据集 通路；评估气体通道的生物安全性。本文件涵盖了医疗器械生物相容性评估的一般原则 构成气体通道的材料，但不包括任何 机械故障，除非故障会带来毒性风险（例如产生颗粒物）。这个 ISO 18562的其他部分包括针对以下潜在危险物质的特定测试 添加到可呼吸气流中，并建立这些物质的验收标准。 本文件阐述了气体通道产生的气流的潜在污染 在医疗设备内，然后可能会对患者进行治疗。本文件适用于医疗器械在正常使用和使用中的预期使用寿命 考虑任何预期加工或再加工的影响。本文件不涉及直接接触的医疗器械表面的生物学评估 与患者接触。直接接触表面的要求见ISO 10993系列。包含本文件所述气体通道的医疗设备、零件或附件 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、氧气保存设备、氧气浓缩器、雾化器、低压软管 组件、加湿器、热湿交换器、呼吸气体监测器、呼吸监测器、， 口罩、口罩、复苏器、呼吸管、呼吸系统过滤器和Y形管以及 拟与此类医疗设备一起使用的任何呼吸配件。封闭的房间 包括床垫在内的培养箱和氧气罩的内表面被认为是气体 本文件还介绍了路径和方法。交叉引用:ISO 7396-1:2016ISO 10993-1:2009ISO 10993-17:2002ISO 14971:2007ISO 18562-2ISO 18562-3ISO 18562-4ISO 10993-9ISO 10993-13ISO 10993-14ISO 10993-15ISO 13485:2016ISO 16142-1:2016ISO/IEC 17025IEC 60601-1:2005IEC 60601-1:2005/A1:2012BS 5724-3.12购买本文件时可提供的所有现行修改件均包括在购买时。

BS ISO 18562-1:2017 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.This document does not address biological evaluation of the surfaces of medical devices that are in 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 equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical 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.Cross References:ISO 7396-1:2016ISO 10993-1:2009ISO 10993-17:2002ISO 14971:2007ISO 18562-2ISO 18562-3ISO 18562-4ISO 10993-9ISO 10993-13ISO 10993-14ISO 10993-15ISO 13485:2016ISO 16142-1:2016ISO/IEC 17025IEC 60601-1:2005IEC 60601-1:2005/A1:2012BS 5724-3.12All current amendments available at time of purchase are included with the purchase of this document.