EN 60601-2-43:2010

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

Publication date:   Sep 16, 2010

General information

60.60 Standard published   Jun 11, 2010

CENELEC

CLC/TC 62 Electrical equipment in medical practice

European Norm

11.040.50   Radiographic equipment | 37.040.25   Radiographic films

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Scope

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.

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

PREVIOUSLY

WITHDRAWN
EN 60601-2-43:2000

NOW

PUBLISHED
EN 60601-2-43:2010
60.60 Standard published
Jun 11, 2010

CORRIGENDA / AMENDMENTS

PUBLISHED
EN 60601-2-43:2010/A1:2018

PUBLISHED
EN 60601-2-43:2010/A2:2020

PUBLISHED
EN 60601-2-43:2010/AC:2014

REVISED BY

PUBLISHED
EN IEC 60601-2-43:2023