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IEC 60601-2-43:2010+AMD1:2017+AMD2:2019 CSV被替代

Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures

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基本信息
标准编号: IEC 60601-2-43:2010+AMD1:2017+AMD2:2019 CSV
标准类别:Standard
出版单位:
标准页数:0
标准简介

IEC 60601-2-43:2010+A1:2017+A2:2019 establishes particular basic safety and essential performance requirements for the design and manufacture of X ray equipment for radioscopically guided interventional procedures. It specifies information which is to be provided with such interventional X-ray equipment for the assistance of the responsible organization and operator in managing the radiation risk and equipment failure risk arising from these procedures which could affect patients or staff. This second edition cancels and replaces the first edition published in 2000. This particular standard has been revised to provide a complete set of safety requirements for X-ray equipment for radioscopically guided interventional procedures, based on the third edition of IEC 60601-1 and relevant collaterals. The present edition is extended to become a system standard for X-ray equipment designed for the use during interventional procedures using X-ray imaging, whether of prolonged or normal duration. This consolidated version consists of the second edition (2010), its amendment 1 (2017) and its amendment 2 (2019). Therefore, no need to order amendment in addition to this publication.