IEC 60601-2-43:2010+AMD1:2017 CSV 
Consolidated version

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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Abstract

IEC 60601-2-43:2010+A1:2017 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) and its amendment 1 (2017). Therefore, no need to order amendment in addition to this publication.

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Additional information

Publication typeInternational Standard
Publication date2017-05-31
Edition2.1
Available language(s)English/French
TC/SCTC 62/SC 62B - Diagnostic imaging equipmentrss
ICS11.040.50 - Radiographic equipment
37.040.25 - Radiographic films
Stability date  2019
Pages227
File size2975 KB

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