BS EN 60601-2-11:2015 - Medical electrical equipment. Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

BS EN 60601-2-11:2015

Medical electrical equipment. Particular requirements for the basic safety and essential performance of gamma beam therapy equipment

Status : Current   Published : June 2015

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IEC 60601-2-11:2013 applies to the basic safety and essential performance of gamma beam therapy equipment, including multi-source stereotactic radiotherapy equipment. This particular standard of the 60601 series, establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. It states tolerance limits beyond which interlocks must prevent, interrupt or terminate irradiation in order to avoid an unsafe condition. Type tests which are performed by the manufacturer, or site tests, which are not necessarily performed by the manufacturer, are specified for each requirement. It does not attempt to define the optimum performance requirements for a gamma beam therapy equipment for use in radiotherapy. Its purpose is to identify those features of design which are regarded at the present time as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance at which it can be presumed that a fault condition applies, e.g. a component failure, and where an interlock then operates to prevent continued operation. This third edition cancels and replaces the second edition of IEC 60601-2-11 published in 1997 and its Amendment 1:2004. This edition constitutes a technical revision which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.




Standard NumberBS EN 60601-2-11:2015
TitleMedical electrical equipment. Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
StatusCurrent
Publication Date30 June 2015
Normative References(Required to achieve compliance to this standard)EN 61217, EN 60601-1-3:2008, IEC/TR 60788:2004, IEC 61217, IEC 60601-1-3:2008, EN 60601-1-3:2008/Corrigendum 1:2010
Informative References(Provided for Information)93/42/EEC
ReplacesBS EN 60601-2-11:1998, BS 5724-2.11:1998 IEC 60601-2-
International RelationshipsEN 60601-2-11:2015,IEC 60601-2-11:2013
Draft Superseded By10/30183024 DC
DescriptorsElectrical medical equipment, Marking, Graduations, Medical radiology, Design, Electrical safety, Testing conditions, Radiology apparatus (medical), Identification methods, Radiotherapy, Direction of movement, Components, Gamma-ray apparatus, Medical equipment, Instructions for use, Electrical equipment, Radiology, Radiation protection, Safety engineering, Electronic equipment and components, Radiation hazards, Environment (working), Control devices, Accident prevention, Documents, Signal devices, Therapeutics, Safety measures
ICS11.040.50
11.040.60
Title in FrenchAppareils électromédicaux. Exigences particulières pour la sécurité de base et les performances essentielles des appareils de gammathérapie
Title in GermanMedizinische elektrische Geräte. Besondere Festlegungen für die Strahlensicherheit von Gamma-Bestrahlungseinrichtungen
CommitteeCH/62/3
ISBN978 0 580 63288 4
PublisherBSI
FormatA4
DeliveryYes
Pages56
File Size1.445 MB
Price£254.00


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