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CSA C22.2 NO 60601-2-45

Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

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Organization: CSA
Publication Date: 1 January 2011
Status: active
Page Count: 128
ICS Code (Radiographic equipment): 11.040.50
scope:

This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also referred to as ME EQUIPMENT.

NOTE 1 This includes MAMMOGRAPHIC X-RAY EQUIPMENT using integrated digital X-RAY IMAGE RECEPTORS or integrated storage phosphor subsystems.

Excluded from the scope of this document are:

- reconstructive tomography modes of operation;

- diagnostic consoles;

- picture archiving and communication systems (PACS);

- non-integrated storage phosphor readers;

- hard copy cameras;

- films, screens and cassettes;

- computer aided detection (CAD);

- devices for performing core biopsy and other biopsy instruments;

- modes of operation intended to demonstrate local contrast medium uptake (contrast enhanced digital mammography);

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 2 IEC 60601-2-7:1998 and IEC 60601-2-32 are not part of the 3rd edition scheme for MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES.

Document History

January 1, 2017
Amendment 1:2017 (IDT) to CAN/CSA-C22.2 No. 60601-2-45:11 Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
A description is not available for this item.
Medical electrical equipment — Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
Replacement: This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also referred to as ME...
CSA C22.2 NO 60601-2-45
January 1, 2011
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also referred to as ME EQUIPMENT....
Medical Electrical Equipment - Part 2-45: Particular Requirements for the Safety of Mammographic X-Ray Equipment and Mammographic Stereotactic Devices
Addition: This Particular Standard contains requirements for the safety of X-RAY EQUIPMENT designed for mammography and MAMMOGRAPHIC STEREOTACTIC DEVICES. The safety requirements for the X-RAY...
Medical Electrical Equipment - Part 2-45: Particular Requirements for the Safety of Mammographic X-Ray Equipment and Mammographic Stereotactic Devices
A description is not available for this item.
Medical Electrical Equipment - Part 2-45: Particular Requirements for the Safety of Mammographic X-Ray Equipment and Mammographic Stereotactic Devices
A description is not available for this item.

References

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