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Publication details

Publication CODE Title
IEC 60601-2-43:2010+AMD1:2017+AMD2:2019 CSV (2019-10) MEDICAL ELECTRICAL EQUIPMENT - PART 2-43: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF X-RAY EQUIPMENT FOR INTERVENTIONAL PROCEDURES
 
Price Excl. VAT Total number of pages, tables and drawings
636.00 € 264.
Description
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.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN/FR version

Status
Status IEC PUBLICATION
Situation Withdrawn
Replaced by  IEC 60601-2-43:2022
Origin
Committee TC 62/SC 62B
DIAGNOSTIC IMAGING EQUIPMENT
Approval
BEC Approval 2019-10-16
ICS-Code (International Standards Classification) 11.040.50
NBN Status New
IEC publication date 2019-10-16
IEC stability date 2020-12-31
IEC file modification date 2019-10-16
IEC last modification date 2020-01-02