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CEI EN 60601-2-45

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

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Organization: CEI
Publication Date: 1 April 2016
Status: active
Page Count: 20
ICS Code (Radiographic equipment): 11.040.50
scope:

Add, in the first paragraph, after the term "MAMMOGRAPHIC X-RAY EQUIPMENT" the phrase "including equipment for MAMMOGRAPHIC TOMOSYNTHESIS,".

Replace, in the first dashed item of the third paragraph, the words "modes of operation" by "other than MAMMOGRAPHIC TOMOSYNTHESIS"

Add, after this first dashed item, the following new dashed item:

- CT SCANNERS covered by IEC 60601-2-44;

Document History

CEI EN 60601-2-45
April 1, 2016
Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
Add, in the first paragraph, after the term "MAMMOGRAPHIC X-RAY EQUIPMENT" the phrase “including equipment for MAMMOGRAPHIC TOMOSYNTHESIS,“. Replace, in the first dashed item of the third paragraph,...
February 1, 2012
Medical electrical equipment Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
Replacement: This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAMMOGRAPHIC X-RAY EQUIPMENT and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also referred to as ME...
April 1, 2002
Medical electrical equipment - Part 2: Particular requirements for the safety of mammographic X-ray equipment and mammographic stereotactic devices
La Norma riguarda la sicurezza dei dispositivi stereotassici per mammografia che permettono la localizzazione tridimensionale di un punto all'interno della mammella e consentono di guidare...
November 1, 1999
Apparecchi elettromedicali - Parte 2: Norme particolari per la sicurezza degli apparecchi radiologici per mammografia e dispositivi stereotassici per mammografia
La Norma riguarda la sicurezza dei dispositivi stereotassici per mammografia che permettono la localizzazione tridimensionale di un punto all'interno della mammella e consentono di guidare...

References

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