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SRPS EN 60601-2-45:2012/A2:2025

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

Dec 31, 2025

General information

90.93     Jan 5, 2026

90.00    Jan 5, 2031

ISS

N062

European Norm

11.040.50  

English  

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Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

93/42/EEC

Medical devices

Life cycle

PREVIOUSLY

PUBLISHED
SRPS EN 60601-2-45:2012

NOW

PUBLISHED
SRPS EN 60601-2-45:2012/A2:2025
90.93 Standard confirmed
Jan 5, 2026

Related project

Adopted from EN 60601-2-45:2011/A2:2024

Adopted from IEC 60601-2-45:2011/AMD2:2022 ED3 IDENTICAL