标准摘要
[中文适用范围]： 本文件规定了在医疗设备、其部件或附件的风险管理过程中，涉及提供呼吸护理或通过呼吸道向患者输送物质的气体通路进行生物评估的一般原则；根据与气流接触的性质和持续时间对气体通路进行的一般分类；从所有来源评估现有相关数据；基于风险分析识别可用数据集中的差距；确定必要的额外数据集以分析气体通路的生物安全性；评估气体通路的生物安全性。本文件涵盖在正常使用和正常条件下，医疗设备材料（构成气体通路）的生物相容性评估的一般原则。本文件不涵盖由机械损坏引起的生物学危害。ISO 18562的其他部分涵盖了特定测试，这些测试针对添加到可呼吸气流中的潜在有害物质，并建立了这些物质的接受标准。本文件关注可能源自医疗设备内部气体通路的气流污染，该污染随后可能传递给患者。本文件适用于根据使用说明操作时预期的医疗设备使用寿命。这包括因暴露于环境条件而引起的退化以及清洁、消毒和灭菌（即处理）所导致的退化。它还包括可能导致意外或未预料结果（结果）的用户行为或无行为（疏忽），例如使用错误。本文件不包括有意违反使用说明并超出制造商合理风险控制的行为（即异常使用）。本文件不涵盖直接接触患者或用户的医疗器械表面的生物学评估。直接接触表面的要求可以在ISO 10993系列中找到。由本文件涉及气体通路的医疗设备、部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、氧气储蓄设备、氧 concentrator、雾化器、低压软管组件、加湿器、热湿交换器、呼吸气体监测仪、呼吸监测仪、面罩、医用呼吸个人防护装备、口咽通气道、复苏器、呼吸管道、呼吸系统过滤器和Y形件以及任何旨在与此类医疗设备一起使用的呼吸配件。孵化器的封闭室，包括床垫，以及氧气罩的内表面也被视为气体通路并由本文件涵盖。本文件不涵盖在医疗设备正常使用时从气源供应的已存在污染。示例 从医用气体管道系统（包括管道出口处的止回阀）、连接或集成于医用气体钢瓶的压力调节器出口，或被引入到医疗器械中的房间空气等气源到达医疗器械的污染物未包含在ISO 18562（所有部分）中。 [外文原描述]： 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 , in normal use and normal condition . This document does not cover biological hazards arising from mechanical damage. 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 lifetime of the medical device when operated according to the instructions for use. This includes degradation arising from exposure to environmental conditions as well as cleaning, disinfection and sterilisation (i.e. processing ). It also includes user action or inaction (omission) that leads to an unintended or unexpected outcome (result) (i.e. use error ). It does not include conscious/intentional action or inaction that violates the instructions for use and is beyond reasonable risk control by the manufacturer (i.e. abnormal use ). This document does not address biological evaluation of the surfaces of medical devices that have direct contact with the patient or user . 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, medical respiratory personal protective equipment, 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. This document 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).
英文名称Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process