Norm

NEN-EN-IEC 60601-2-1:2015 en

Medische elektrische toestellen - Deel 2-1: Bijzondere eisen voor de veiligheid van medische elektronenversnellers in het gebied van 1 MeV tot 50 MeV

253,59

Over deze norm

Status Definitief
Aantal pagina's 263
Commissie Medische elektrische toestellen
Gepubliceerd op 01-10-2015
Taal Engels
NEN-EN-IEC 60601-2-1+A1 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 MeV, used for treatment of PATIENTS. This particular standard, with the inclusion of TYPE TESTS and SITE TESTS, applies respectively to the manufacture and some installation aspects of ELECTRON ACCELERATORS - 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, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of XRADIATION and/or ELECTRON RADIATION having - NOMINAL ENERGY in the range 1 MeV to 50 MeV, - maximum ABSORBED DOSE RATES between 0,001 Gy × s-1 and 1 Gy × s-1 at 1 m from the RADIATION SOURCE, - NORMAL TREATMENT DISTANCES (NTDs) between 0,5 m and 2 m from the RADIATION SOURCE, 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, e.g. STATIONARY RADIOTHERAPY or MOVING BEAM RADIOTHERAPY, - 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.

Details

ICS-code 11.040.60
Nederlandse titel Medische elektrische toestellen - Deel 2-1: Bijzondere eisen voor de veiligheid van medische elektronenversnellers in het gebied van 1 MeV tot 50 MeV
Engelse titel Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV
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