Norm

NEN-EN-IEC 60601-2-36:2015 en

Medische elektrische toestellen - Deel 2-36: Bijzondere eisen voor de veiligheid van toestellen voor vanaf buiten het lichaam opgewekte blaassteenvergruizing

117,74

Over deze norm

Status Definitief
Aantal pagina's 41
Commissie Medische elektrische toestellen
Gepubliceerd op 01-06-2015
Taal Engels
NEN-EN-IEC 60601-2-36 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of equipment for EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 201.3.206 including equipment for other medical applications of therapeutic extracorporeally induced focused PRESSURE PULSES, hereafter referred to as ME EQUIPMENT. The applicability of this particular standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging and monitoring devices. Other devices, such as PATIENT treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other applicable IEC standards. This particular standard does not apply to: - ULTRASOUND PHYSIOTHERAPY EQUIPMENT intended to be used for physiotherapy; - ULTRASOUND equipment intended to be used for high intensity therapeutic ULTRASOUND (HITU) and other therapy equipment as described in Annex AA;

Details

ICS-code 11.040.01
Nederlandse titel Medische elektrische toestellen - Deel 2-36: Bijzondere eisen voor de veiligheid van toestellen voor vanaf buiten het lichaam opgewekte blaassteenvergruizing
Engelse titel Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy
Vervangt
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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