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Full Description

Scope:

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.
 

Document History

  1. CSA C22.2 NO. 60601-2-44:10 (R2019)

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    Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Adopted IEC 60601-2-44:2009), Includes Corrigendum 1:2011 | Appareils electromedicaux-Partie 2-44: Exigences particulieres etc.

    • Most Recent
  2. CAN/CSA C22.2 NO. 60601-2-44-03(R07)


    Medical Electrical Equipment - Part 2-44: Particular Requirements for the Safety of X-Ray Equipment for Computed Tomography (Adopted IEC 60601-2-44:2001, second edition, 2001-06)

    • Historical Version
 

Amendments, rulings, supplements, and errata

  1. CSA C22.2 NO. 60601-2-44B-10 (R2019)


    Amendment 2:2018 to CAN/CSA-C22.2 NO. 60601-2-44-10, Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Adopted IEC 60601-2-44:2009), Includes Corrigendum 1:2011

  2. CSA C22.2 NO. 60601-2-44A-10 (R2019)


    Amendment 1:2014 to CAN/CSA-C22.2 NO. 60601-2-44-10, Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (Adopted IEC 60601-2-44:2009), Includes Corrigendum 1:2011