IEC 60601-2-45:2011+AMD1:2015 CSV (Consolidated version)
Medical electrical equipment - Part 2-45: Particular requirementsfor basic safety and essential performance of mammographic X-ray equipment and mammomagraphic stereotactic devices
Appareils électromédicaux - Partie 2-45: Exigences particulièrespour la sécurite de base et les performances essentielles des appareils de mammographie à rayonnement X et des appareilsmammographiques steréotaxiques
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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Mandatory Standard according current regulation