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IEC 60601-2-45 Ed. 3.1现行

Medical electrical equipment Part 2-45: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammomagraphic stereotactic devices

出版:International Electrotechnical Committee

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基本信息
标准编号: IEC 60601-2-45 Ed. 3.1
发布时间:2015/6/18 0:00:00
标准类别:Standard
出版单位:International Electrotechnical Committee
标准页数:105
标准简介

IEC 60601-2-45:2011+A1:2015 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment. This consolidated version consists of the third edition (2011) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.

本标准替代的旧标准

IEC 60601-2-45 Ed. 3.0

等同采用的国际标准

AS/NZS IEC 60601.2.45:2015 - Identical