ČSN EN IEC 60601-2-64-ed.2

Detailinformationen

Bezeichnung: ČSN EN IEC 60601-2-64-ed.2

Ausgabedatum: 01.06.2026

Seiten: 68

Land: Tschechische technische Norm

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Erhältlich auf www.technormen.de

Annotation

This document applies to the basic safety and essential performance of light ion beam ME EQUIPMENT, he-reafter referred to as ME EQUIPMENT, used for treatment of patients.
This document, with the inclusion of type tests and site tests, applies respectively to the manufacturer and spe-cified installation aspects of light ion beam ME EQUIPMENT
- intended for radiotherapy in human medical practice, including those in which the selection and display of operating parameters can be controlled automatically by programmable electronic subsystems (PESS),
- that, in normal use, deliver a radiation beam of light ions having energy per nucleon in the range 10 MeV/n to 500 MeV/n,
and
- intended to be
- for normal use, operated under the authority of appropriately licensed or qualified persons by operators having the required skills for a particular medical application, for particular specified clinical purposes maintained in accordance with the recommendations given in the instructions for use,
- subject to regular quality assurance performance and calibration checks by a qualified person