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﻿ БДС EN 60601-2-43:2010
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Published: 2010-09-16
The standard is available on PDF file.
Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
IEC 60601-2-43:2010 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.
TC-87 - Medical devices
37.040.25 - Radiographic films
93/42/EEC - Medical devices
Correnspondence with national standards
БДС EN 60601-2-43:2010 supersedes БДС EN 60601-2-43:2004 on 2013-07-15
БДС EN 60601-2-43:2010 supersedes БДС EN 60601-2-54:2010 and withdraw it on (частично)
AC:2014; A1:2018
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