ISO 18562-1:2017 医疗应用中呼吸气体通路的生物相容性评价 第1部分：风险管理流程的评估和测试

标准编号：ISO 18562-1:2017

中文名称：医疗应用中呼吸气体通路的生物相容性评价 第1部分：风险管理流程的评估和测试

英文名称：Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process

发布日期：2017-03

标准范围

ISO 18562-1:2017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；-根据风险分析确定可用数据集中的差距；-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。ISO 18562-1:2017涵盖了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（e。g、 通过产生微粒）。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。ISO 18562-1:2017解决了医疗器械内气体通道产生的气流的潜在污染问题，这些气体可能随后被输送到患者身上。ISO 18562-1:2017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。ISO 18562-1:2017未涉及与患者直接接触的医疗器械表面的生物学评估。直接接触表面的要求见ISO 10993系列。本文件涉及的含有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、雾化器等-压力软管组件、加湿器、热湿交换器、呼吸气体监测仪、呼吸监测仪、面罩、口罩、复苏器、呼吸管、呼吸系统过滤器和Y形件，以及拟与此类医疗设备一起使用的任何呼吸附件。培养箱的封闭室（包括床垫）和氧气罩的内表面被视为气体通道，本文件也对其进行了说明。ISO 18562-1:2017未涉及医疗设备正常使用时，从气源供应的气体中已经存在的污染。例如，ISO 18562（所有部分）未涉及从气源（如医用气体管道系统（包括管道出口中的止回阀）、连接或集成到医用气瓶的压力调节器出口，或进入医疗设备的室内空气）到达医疗设备的污染。未来的部分可能会被添加，以解决生物测试的其他相关方面，包括由于添加到气流中的药物和麻醉剂的存在，气体通道可能产生的额外污染。注1:一些有管辖权的当局要求对这些风险进行评估，作为生物评估的一部分。注2:本文件旨在阐述附件B中所示的相关安全和性能基本原则。

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.ISO 18562-1:2017 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.ISO 18562-1:2017 addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient.ISO 18562-1:2017 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.ISO 18562-1:2017 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.ISO 18562-1:2017 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 is not addressed by ISO 18562 (all parts).Future parts might be added to address other relevant aspects of biological testing including additional contamination that might arise from the gas pathway because of the presence of drugs and anaesthetic agents added to the gas stream.NOTE 1 Some authorities having jurisdiction require evaluation of these risks as part of a biological evaluation.NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.

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