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Publication details

Publication CODE Title
IEC 60601-2-45:2011+AMD1:2015+AMD2:2022 CSV (2022-08) MEDICAL ELECTRICAL EQUIPMENT - PART 2-45: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MAMMOGRAPHIC X-RAY EQUIPMENT AND MAMMOGRAPHIC STEREOTACTIC DEVICES
 
Price Excl. VAT Total number of pages, tables and drawings
480.00 € 228.
Description
IEC 60601-2-45:2011+AMD1:2015+AMD2:2022 applies to the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. IEC 60601-2-45:2011 addresses the system level of mammographic X-ray equipment, which consists of a combination of an X-ray generator, associated equipment and accessories. Components functions are addressed as far as necessary. The minimum safety requirements specified in this particular standard are considered to provide for a practical degree of safety in the operation of mammographic X-ray equipment. Like the previous edition of this Part 2-45, the present third edition includes requirements on high-voltage generators for mammography. This third edition cancels and replaces the second edition published in 2001. This edition constitutes a technical revision. The document has been aligned to the 3rd edition of IEC 60601-1 (2005) and to IEC 60601-1-3 (2010). Further modifications have been made with respect to the current technology of mammographic X-ray equipment.
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN/FR version

Status
Status IEC PUBLICATION
Situation Currently active
Origin
Committee TC 62/SC 62B
DIAGNOSTIC IMAGING EQUIPMENT
Approval
BEC Approval 2022-08-02
ICS-Code (International Standards Classification) 11.040.50
NBN Status New
IEC publication date 2022-08-02
IEC stability date 2025-12-31
IEC file modification date 2022-08-02
IEC last modification date 2022-08-02