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SRPS EN 60601-2-43:2012

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

Dec 20, 2012
Dec 20, 2012

General information

60.60     Dec 20, 2012

ISS

N062

European Norm

37.040.25     11.040.50  

Serbian  

From plan 2010

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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 directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Harmonized

Life cycle

NOW

PUBLISHED
SRPS EN 60601-2-43:2012
60.60 Standard published
Dec 20, 2012

REVISED BY

PUBLISHED
SRPS EN IEC 60601-2-43:2023

Related project

Adopted from EN 60601-2-43:2010