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制定中 prEN ISO 16571
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Systems for evacuation of plume generated by medical devices (ISO/DIS 16571:2023) 医疗设备产生的烟羽排放系统(ISO/DIS 16571:2023)
当前发布的2014版本的完整版本。此外,扩大范围,包括用于内窥镜手术(如微创、腹腔镜)的羽流排空系统。 范围现在如下: 本标准规定了医疗设备排放羽流设备的设计、制造、安装、功能、性能、维护、维修、文件编制、测试和调试的要求和指南。适用于: a) 便携式和移动式烟羽疏散系统, b) 局部固定羽流排放系统, c) 用于羽流排放系统的专用中央管道系统,以及 d) 羽流疏散系统集成到其他设备(例如激光设备)中。
Full revision of currently published 2014 version. Additionally, expand scope to include plume evacuation systems for endoscopic procedures (e.g. minimally invasive, laparoscopic). The scope is now the following: This Standard specifies requirements and guidelines for the design, manufacture, installation, function, performance, maintenance, servicing, documentation, testing, and commissioning of equipment for evacuation of plume generated by medical devices. It is applicable to: a) portable and mobile plume evacuation systems, b) local stationary plume evacuation systems, c) dedicated central pipeline systems for plume evacuation systems, and d) plume evacuation systems integrated into other equipment (e.g. laser equipment).
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归口单位: CEN/TC 215
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