BS EN 60601-2-65:2013 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
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BS EN 60601-2-65:2013

Medical electrical equipment. Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

Status : Current, Under review   Published : July 2013

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PDF

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HARDCOPY



IEC 60601-2-65:2012 applies to the basic safety and essential performance of dental intra-oral X-ray equipment and its main components. The scope of this standard is restricted to X-ray equipment where the X-ray tube assembly contains the high-voltage transformer assembly. Dental extra-oral X-ray equipment is excluded from the scope of this standard. This particular standard has been prepared to provide, based on IEC 60601-1:2005 and its collaterals, a complete set of basic safety and essential performance requirements for dental intra-oral X-ray equipment. While the previously existing standards for such equipment were dedicated to components and subsystems, this particular standard addresses the system level of dental intra-oral X-ray equipment. Components and their functions are addressed as far as necessary.




Standard NumberBS EN 60601-2-65:2013
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment
StatusCurrent, Under review
Publication Date31 July 2013
Normative References(Required to achieve compliance to this standard)EN 60601-1-2:2007, EN 62220-1:2004, EN 60601-1-3:2008, IEC/TR 60788:2004, IEC 60336, IEC 60601-1-3:2008, EN 60336, IEC 62220-1:2003, IEC 60601-1-2:2007
Informative References(Provided for Information)IPSM 64:1991, IEC 60601-2-45:2011, IEC 60601-2-63, IEC 60601-2-28:2010, ICRP PUBLICATION 103, IEC 60601-2-54:2009, IEC 60601-2-43:2010, IEC 60601-2-32:1994, IEC 60601-2-44:2009, IEC 60601-2-7:1998
ReplacesBS EN 60601-2-32:1995, BS 5724-2.32:1995,IEC 60601-2-32:1994, BS EN 60601-2-7:1998, BS 5724-2.7:1998,IEC 60601-2-7:1998
International RelationshipsEN 60601-2-65:2013,IEC 60601-2-65:2012
Draft Superseded By11/30227728 DC
DescriptorsEarthing, High-voltage equipment, Leakage currents, Electric power systems, Environmental testing, Electrical testing, Loading, Test equipment, Electromagnetic compatibility, Medical equipment, Safety measures, Classification systems, Fire risks, Dielectric strength, X-ray apparatus, Accuracy, Electric shocks, Rated voltage, Marking, Reproducibility, Conformity, Electrical safety, Performance testing, Radiation hazards, Medical radiography, Clinical investigation instruments, Type testing, Electronic equipment and components, Safety engineering, Radiology apparatus (medical), Electrical equipment, Electrical medical equipment, Medical radiology, Instructions for use
ICS11.040.50
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires intra-oraux
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von intraoralen zahnärztlichen Röntgeneinrichtungen
CommitteeCH/62/2
ISBN978 0 580 71523 5
PublisherBSI
FormatA4
DeliveryYes
Pages48
File Size1.634 MB
Price£240.00


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