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IEC 60601-2-18 Ed. 3.0现行

Medical electrical equipment Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

出版:International Electrotechnical Committee

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基本信息
标准编号: IEC 60601-2-18 Ed. 3.0
发布时间:2009/8/12 0:00:00
标准类别:Standard
出版单位:International Electrotechnical Committee
标准页数:96
标准简介

IEC 60601-2-18:2009 establishes particular basic safety and essential performance requirements for endoscopic equipment. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of endoscopic equipment. IEC 60601-2-18:2009 amends and supplements IEC 60601-1:2005. This third edition cancels and replaces the second edition, published in 1996, and its Amendment 1 (2000). This edition constitutes a technical revision and has been aligned or harmonized with IEC 60601-1:2005. The main changes with respect to the previous edition include: - alignment of requirements with IEC 60601-1:2005; - inclusion of essential performance requirements; - the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard; - reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests.

本标准替代的旧标准

IEC 60601-2-18 Ed. 2.0

等同采用的国际标准

AS/NZS IEC 60601.2.18:2015 - Identical