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Norm
OVE EN 60601-2-63
Ausgabedatum: 2022 10 01
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment (english version)
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT. The scope inc...
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Herausgeber:
Österreichischer Verband für Elektrotechnik
Format:
Digital | 132 Seiten
Sprache:
Englisch
ICS
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of
DENTAL EXTRA-ORAL X-RAY EQUIPMENT, hereafter also called ME EQUIPMENT. The scope includes
ME SYSTEMS containing such ME EQUIPMENT.
The scope of this standard is restricted to X-RAY EQUIPMENT where:
• the X-RAY TUBE ASSEMBLY contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY and
• the geometrical relations between the X-RAY SOURCE, the anatomical object being imaged
in the PATIENT, and the X-RAY IMAGE RECEPTOR, are preset in the design and cannot be
arbitrarily altered by the OPERATOR during INTENDED USE.
ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-44, IEC 60601-2-54,
IEC 60601-2-45, IEC 60601-2-65 or IEC 60601-2-43 are excluded from the scope of this
particular standard. The scope of this International Standard also excludes RADIOTHERAPY
SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the
scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY.
Within its specific scope, the clauses of this particular standard supersede and replace those
of IEC 60601-2-7, Medical electrical equipment – Particular requirements for the safety of
high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical
electrical equipment – Particular requirements for the safety of associated equipment of X-ray
equipment.
All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular
standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this
International Standard with the exception of X-RAY TUBE ASSEMBLIES that are replaceable in
the field.
OVE EN 60601-2-63
2022 10 01
Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential...
Norm
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OVE EN 60601-2-63
2020 10 01
Medizinische elektrische Geräte - Teil 2-63: Besondere Festlegungen für die Sicherheit einschließlic...
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OVE EN 60601-2-63
2020 10 01
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2016 12 01
Medical electrical equipment -- Part 2-63: Particular requirements for the basic safety and essenti...
Norm
OVE EN 60601-2-63
2016 12 01
Medizinische elektrische Geräte -- Teil 2-63: Besondere Festlegungen für die Sicherheit einschließl...
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