BS ISO 18562-2:2017规定了空气中颗粒物的排放试验 用于提供呼吸护理或供应的医疗器械及其零部件或附件 在所有环境中，通过呼吸道输送给患者的物质。本文件的测试如下: 用于量化从0.2µm直径到10µm直径的颗粒，这些颗粒由 医疗器械及其零部件或附件进入可呼吸气流。本文件确立了 这些测试的验收标准。本文件不涉及纳米颗粒。数据不足 存在以确定直径小于0.2µm颗粒的暴露极限。注1:更小和更大的颗粒也可能带来生物危害，以及外界的其他信息 本文件的范围可能需要满足一些有管辖权的机构的要求。因此，本文件采用了与美国环境保护局（EPA）相同的方法 仅根据颗粒大小而非其化学性质设定限制。本文件阐述了气体通道产生的气流的潜在污染， 然后将其引导至患者。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气体通道表面的生物评估 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、氧气保存装置、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、Y形管和任何呼吸系统 拟与此类装置一起使用的附件。孵化器的封闭室，包括 床垫和氧气罩的内表面被认为是气体通道，也是 本文件所述。本文件不涉及气源供应的气体中已经存在的污染 当医疗设备处于正常使用状态时。例如，来自医疗气体管道等气源的污染到达医疗设备 系统（包括管道出口中的止回阀）、连接的压力调节器出口或 ISO 18562未对医用气瓶或进入医疗设备的室内空气进行规定 （所有部分）。注2:编制本文件的目的是为了说明安全和环境的相关基本原则 性能如附录B所示。交叉引用:ISO 7396-1:2016ISO 14971:2007 ISO 18562-1:2017ISO 7708: 1995年ISO 10993ISO 16142-1:2016ISO 16000-37购买本文件时提供的所有现行修订版均包含在购买本文件中。

BS ISO 18562-2:2017 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.NOTE 1 Smaller and larger particles could also present biological hazards, and additional information outside the scope of this document can be needed to meet requirements of some authorities having jurisdiction.This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.This document addresses potential contamination of the gas stream arising from the gas pathways, which is then 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 gas pathways 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 devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing accessories intended to be used with such 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).NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.Cross References:ISO 7396-1:2016ISO 14971:2007ISO 18562-1:2017ISO 7708:1995ISO 10993ISO 16142-1:2016ISO 16000-37All current amendments available at time of purchase are included with the purchase of this document.