IEC 60601-2-45:2011 ED3

Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices

Publication date:   Feb 10, 2011

General information

60.60 Standard published   Feb 10, 2011

IEC

TC 62/SC 62B Diagnostic imaging equipment

International Standard

11.040.50   Radiographic equipment

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Scope

IEC 60601-2-45:2011 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.

Life cycle

PREVIOUSLY

Revises
IEC 60601-2-45:2001 ED2

NOW

PUBLISHED
IEC 60601-2-45:2011 ED3
60.60 Standard published
Feb 10, 2011

CORRIGENDA / AMENDMENTS

Amended by
IEC 60601-2-45:2011/AMD1:2015 ED3

Amended by
IEC 60601-2-45/AMD2 ED3