Norm

NEN-EN-IEC 60601-2-17:2004 en

Medische elektrische toestellen - Deel 2-17: Speciale eisen voor de veiligheid van automatisch gereguleerde brachytherapie afterloading apparatuur

  • Deze norm is ingetrokken sinds 08-06-2015

58,16

Over deze norm

Status Ingetrokken
Aantal pagina's 32
Commissie Medische elektrische toestellen
Gepubliceerd op 01-05-2004
Taal Engels
The use of afterloading equipment for brachytherapy purposes may expose patients to danger if the equipment fails to deliver the required dose to the patient, or if the equipment design does not satisfy standards of electrical and mechanical safety. The equipment may also cause danger to persons in the vicinity if the equipment itself fails to contain the radioactive source(s) adequately within the storage container(s) and/or if there are inadequacies in the design of the treatment room. This Particular Standard establishes requirements to be complied with by manufacturers in the design and construction of afterloading equipment for use in temporary brachytherapy procedures. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to return the radioactive source(s) to the storage container(s) and afterwards to prevent continued operation of the equipment.

Details

ICS-code 11.040.60
19.100
Nederlandse titel Medische elektrische toestellen - Deel 2-17: Speciale eisen voor de veiligheid van automatisch gereguleerde brachytherapie afterloading apparatuur
Engelse titel Medical electrical equipment - Part 2-17 : Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
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Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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