UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

CENELEC - EN 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

inactive
Organization: CENELEC
Publication Date: 1 March 2011
Status: inactive
Page Count: 56
ICS Code (Radiographic equipment): 11.040.50
scope:

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 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

March 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....
EN 60601-2-45
March 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
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...
July 1, 2001
Medical Electrical Equipment Part 2-45: Particular Requirements for the Safety of Mammographic X-Ray Equipment and Mammographic Sterotactic Devices
A description is not available for this item.
November 1, 1998
Medical Electrical Equipment Part 2-45: Particular Requirements for the Safety of Mammographic X-Ray Equipment and Mammographic Sterotactic Devices
A description is not available for this item.

References

Advertisement