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DIN EN 60601-2-45 VDE 0750-2-45:2025-12

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 + A2:2022); German version EN 60601-2-45:2011 + A1:2015 + A2:2024
Class/Status: Standard, valid
Released: 2025-12
VDE Art. No.: 0701627

Note: You can pre-order this document (delivery subject to availability). Valid from 2025-12-01.

This second amendment to the third edition of this particular standard has been prepared to provide a complete set of safety requirements for Mammographic X Ray Equipment, based on the second amendment (2020) to IEC 60601-1:2005 and associated collateral standards. This particular standard addresses the system level of Mammographic X Ray Equipment including the equipment for Mammographic Tomosynthesis.

This Document is related to the following Topics (in bold):

11	HEALTH CARE TECHNOLOGY
11.020	Medical sciences and health care facilities in general
11.040	Medical equipment
11.060	Dentistry
11.080	Sterilization and disinfection
11.100	Laboratory medicine
11.140	Hospital equipment
11.180	Aids for disabled or handicapped persons

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DIN EN 60601-2-45 VDE 0750-2-45:2025-12

Medical electrical equipment

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

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