Publication CODE |
Title |
IEC 60601-2-45:2011+AMD1:2015 CSV (2015-06) |
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 |
514.00 €
|
105 P.. |
Description
IEC 60601-2-45:2011+A1:2015 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. This consolidated version consists of the third edition (2011) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.
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Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
Status |
IEC PUBLICATION |
Situation |
Currently active
|
|
Committee |
TC 62/SC 62B
DIAGNOSTIC IMAGING EQUIPMENT
|
BEC Approval |
2015-06-18 |
ICS-Code (International Standards Classification) |
11.040.50
|
NBN Status |
New |
|
IEC publication date |
2015-06-18 |
IEC stability date |
2020-12-31 |
IEC file modification date |
2015-06-18 |
IEC last modification date |
2020-07-22 |
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