ČSN EN IEC 60601-2-64-ed.2 (364801)

Kategorie - podobné normy:

Radiografická zařízení
Terapeutická zařízení

Anotace textu normy ČSN EN IEC 60601-2-64-ed.2 (364801):

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