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IEC 60601-2-45 Consolidated version

IEC 60601-2-45:2011+AMD1:2015 CSV
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
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.
CONSOLIDATED VERSION
Consolidated version

The content of amendment(s) is incorporated into the publication. The track changes mode shows where the publication has been modified by the amendment.

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Technical committee

TC 62/SC 62B Medical imaging equipment, software, and systems
Publication typeInternational Standard
Publication date2015-06-18
Edition3.1
ICS

11.040.50

Stability date2025
ISBN number9782832228098
Pages105
File size1.76 MB
EditionDatePublicationEditionStatus
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