Norm

NEN-EN-IEC 60601-2-43:2010 en

Medische elektrische toestellen - Deel 2-43: Bijzondere eisen voor de veiligheid en essenti?le prestatie van r?ntgentoestellen voor interventieprocedures

Volledig inclusief:

226,42

Over deze norm

Status Definitief
Aantal pagina's 56
Commissie Medische elektrische toestellen
Gepubliceerd op 01-06-2010
Taal Engels
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, hereafter referred to as INTERVENTIONAL X-RAY EQUIPMENT. Its scope excludes, in particular: - equipment for RADIOTHERAPY; - equipment for COMPUTED TOMOGRAPHY; - ACCESSORIES intended to be introduced into the PATIENT; - mammographic X-RAY EQUIPMENT; - dental X-RAY EQUIPMENT. INTERVENTIONAL X-RAY EQUIPMENT declared by the MANUFACTURER to be suitable for RADIOSCOPICALLY GUIDED INTERVENTIONAL PROCEDURES, which does not include a PATIENT SUPPORT as part of the system, is exempt from the PATIENT SUPPORT provisions of this standard. If a clause or subclause is specifically intended to be applicable to INTERVENTIONAL X-RAY 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 INTERVENTIONAL X-RAY EQUIPMENT and to ME SYSTEMS, as relevant.

Details

ICS-code 11.040.50
37.040.25
Nederlandse titel Medische elektrische toestellen - Deel 2-43: Bijzondere eisen voor de veiligheid en essenti?le prestatie van r?ntgentoestellen voor interventieprocedures
Engelse titel Medical electrical equipment - Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures
Vervangt
Gewijzigd door
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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