Norm

IEC 60601-2-45:2011+A1:2015 en

Medische elektrische toestellen - Deel 2-45: Bijzondere eisen voor de veiligheid en essentiële prestatie van röntgentoestellen en stereotactische toestellen voor mammografie

315,75

Over deze norm

Status Definitief
Aantal pagina's 105
Commissie Medische elektrische toestellen
Gepubliceerd op 01-06-2015
Taal Engels
This international standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MAMMOGRAPHIC X-RAY EQUIPMENT, including equipment for MAMMOGRAPHIC TOMOSYNTHESIS, and MAMMOGRAPHIC STEREOTACTIC DEVICES, hereafter also referred to as ME EQUIPMENT. Excluded from the scope of this document are: - reconstructive tomography other than MAMMOGRAPHIC TOMOSYNTHESIS; - CT SCANNERS covered by IEC 60601-2-44; - diagnostic consoles; - picture archiving and communication systems (PACS); - non-integrated storage phosphor readers; - hard copy cameras; - films, screens and cassettes; - computer aided detection (CAD); - devices for performing core biopsy and other biopsy instruments; - modes of operation intended to demonstrate local contrast medium uptake (contrast enhanced digital mammography); If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant.

Details

ICS-code 11.040.50
Nederlandse titel Medische elektrische toestellen - Deel 2-45: Bijzondere eisen voor de veiligheid en essentiële prestatie van röntgentoestellen en stereotactische toestellen voor mammografie
Engelse titel 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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