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OVE EN IEC 60601-2-1
Ausgabedatum: 2023 01 01
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 (english version)
This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ELECTRON
ACCELERATORS, hereafter referred to as ME EQUIPMENT, in the range 1 MeV to 50 Me...
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Gültig
Herausgeber:
Österreichischer Verband für Elektrotechnik
Format:
Digital | 242 Seiten
Sprache:
Englisch
ICS
Fachgebiete
This part of IEC 60601 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 to the
manufacture and some installation aspects of ELECTRON ACCELERATORS and their included
equipment used to increase the precision, accuracy and volumetric targeting of the TREATMENT
delivery
– intended for RADIOTHERAPY in medical practice, including those in which the selection and
DISPLAY of TREATMENT PARAMETERS can be controlled automatically by PROGRAMMABLE
ELECTRONIC SUBSYSTEMS (PESS),
– that, under NORMAL CONDITIONS and in NORMAL USE, deliver a RADIATION BEAM of X-RADIATION
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 the ERP from
the RADIATION SOURCE, and
• REFERENCE TREATMENT DISTANCES (RTDs) between 0,5 m and 2 m from the RADIATION
SOURCE;
and
– intended to be
• for NORMAL USE, operated under the authority of the RESPONSIBLE ORGANIZATION by
QUALIFIED PERSONS appropriately licensed or 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,
and
• subject to regular QUALITY ASSURANCE performance and calibration checks by a QUALIFIED
PERSON.
OVE EN IEC 60601-2-1
2023 01 01
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential ...
Norm
↖
OVE EN 60601-2-1
2016 09 01
Medizinische elektrische Geräte -- Teil 2-1: Besondere Festlegungen für die Sicherheit einschließli...
Norm
OVE EN 60601-2-1
2016 09 01
Medical electrical equipment -- Part 2-1: Particular requirements for the basic safety and essentia...
Norm
ÖVE/ÖNORM EN 60601-2-1
2007 07 01
Medizinische elektrische Geräte - Teil 2-1: Besondere Festlegungen für die Sicherheit von Elektronen...
Norm
ÖVE/ÖNORM EN 60601-2-1
2002 09 01
Medizinische elektrische Geräte - Teil 2-1: Besondere Festlegungen für die Sicherheit von Elektronen...
Norm
ÖVE EN 60601-2-1
1998 12 14
Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelera...
Technische Regel