IEC 60601-2-43:2010 ED2

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

Publication date:   Oct 16, 2019

General information

99.60 Withdrawal effective   Dec 5, 2022

IEC

TC 62/SC 62B

International Standard

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.

Life cycle

PREVIOUSLY

WITHDRAWN
IEC 60601-2-32:1994 ED1

WITHDRAWN
IEC 60601-2-43:2000 ED1

NOW

WITHDRAWN
IEC 60601-2-43:2010 ED2
99.60 Withdrawal effective
Dec 5, 2022

CORRIGENDA / AMENDMENTS

WITHDRAWN
IEC 60601-2-43:2010/AMD1:2017 ED2

WITHDRAWN
IEC 60601-2-43:2010/AMD2:2019 ED2

REVISED BY

PUBLISHED
IEC 60601-2-43:2022 ED3