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IEC 60601-2-44

Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography

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Organization: IEC
Publication Date: 1 March 2016
Status: active
Page Count: 282
ICS Code (Radiographic equipment): 11.040.50
scope:

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT SCANNERS, hereafter also referred to as ME EQUIPMENT.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

NOTE 1 See also 4.2 of the general standard.

The scope of this document is limited to CT SCANNERS intended to be used for both head and body characterised by an ENCLOSURE of the X-ray source(s) and imaging detector(s) in a common protective cover in the shape of a toroid. It includes safety requirements for the XRAY GENERATORS used in CT SCANNERS, including those where HIGH-VOLTAGE GENERATORS are integrated with an X-RAY TUBE ASSEMBLY.

NOTE 2 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or this edition of IEC 60601-2-44. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the 3rd edition scheme for COMPUTED TOMOGRAPHY.

The scope of this International Standard excludes RADIOTHERAPY SIMULATORS and systems where the image is created by a source other than an X-RAY TUBE.

Document History

IEC 60601-2-44
March 1, 2016
Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT SCANNERS, hereafter also referred to as ME EQUIPMENT. If a clause or subclause is specifically...
March 1, 2016
AMENDMENT 2 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
A description is not available for this item.
September 1, 2012
Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of CT SCANNERS, hereafter also referred to as ME EQUIPMENT. If a clause or subclause is specifically...
August 1, 2012
AMENDMENT 1 Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
A description is not available for this item.
May 1, 2010
Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography CORRIGENDUM 1
Addition: This Particular Standard applies to X-RAY EQUIPMENT for COMPUTED TOMOGRAPHY (CT SCANNERS). Includes safety requirements for the X-RAY GENERATOR, and those where HIGH VOLTAGE GENERATORS are...
February 1, 2009
Medical electrical equipment – Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography
Addition: This Particular Standard applies to X-RAY EQUIPMENT for COMPUTED TOMOGRAPHY (CT SCANNERS). Includes safety requirements for the X-RAY GENERATOR, and those where HIGH VOLTAGE GENERATORS are...
April 1, 2006
Medical electrical equipment – Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography CORRIGENDUM 1
Addition: This Particular Standard applies to X-RAY EQUIPMENT for COMPUTED TOMOGRAPHY (CT SCANNERS). It includes safety requirements for the X-RAY GENERATOR, and those where HIGH VOLTAGE GENERATORS...
April 1, 2006
Medical electrical equipment – Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography Amendment 1 CORRIGENDUM 1
Addition: This Particular Standard applies to X-RAY EQUIPMENT for COMPUTED TOMOGRAPHY (CT SCANNERS). Includes safety requirements for the X-RAY GENERATOR, and those where HIGH VOLTAGE GENERATORS are...
November 1, 2002
Medical electrical equipment – Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography
Addition: This Particular Standard applies to X-RAY EQUIPMENT for COMPUTED TOMOGRAPHY (CT SCANNERS). It includes safety requirements for the X-RAY GENERATOR, and those where HIGH VOLTAGE GENERATORS...
June 1, 2001
Amendment 1 Medical electrical equipment - Part 2-44: Particular requirements for the safety of X-ray equipment for computed tomography
A description is not available for this item.
June 1, 2001
Medical Electrical Equipment - Part 2-44: Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography
A description is not available for this item.
February 1, 1999
Medical Electrical Equipment - Part 2-44: Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography
A description is not available for this item.

References

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