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IEC 60601-2-45 Ed. 3.2 b:2022

Medical electrical equipment - Part 2-45: Particular requirements for basic safety and essential performance of mammographic X-ray equipment and mammomagraphic stereotactic devices
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IEC 60601-2-45 Ed. 3.2 b:2022

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

PUBLISH DATE 2026
PAGES 236
IEC 60601-2-45 Ed. 3.2 b:2022
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+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.
SDO IEC: International Electrotechnical Commission
Document Number IEC 60601
Publication Date April 1, 2026
Language b - English & French
Page Count 236
Revision Level 3.2
Supercedes
Committee 62B
Publish Date Document Id Type View
April 1, 2026 IEC 60601-2-45 Ed. 3.2 b:2022 Revision
April 1, 2026 IEC 60601-2-45 Ed. 3.1 b:2015 Revision
April 1, 2026 IEC 60601-2-45 Ed. 3.0 b:2011 Revision
Aug. 1, 2022 Revision
June 1, 2015 Revision
Feb. 1, 2011 Revision