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  • BSI
    BS EN 60601-2-11:2015 - TC Tracked Changes. Medical electrical equipment - Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
    Edition: 2020
    $736.46
    / user per year

Description of BS EN 60601-2-11:2015 - TC 2020

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 - TC
TitleTracked Changes. Medical electrical equipment - Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
StatusDefinitive
Publication Date2020-02-26
DescriptorsSafety measures, Therapeutics, Signal devices, Documents, Accident prevention, Control devices, Environment (working), Radiation hazards, Electronic equipment and components, Safety engineering, Radiation protection, Radiology, Electrical equipment, Instructions for use, Medical equipment, Gamma-ray apparatus, Components, Direction of movement, Radiotherapy, Identification methods, Radiology apparatus (medical), Testing conditions, Electrical safety, Design, Medical radiology, Graduations, Marking, Electrical medical equipment
ICS11.040.60 Therapy equipment, 11.040.50 Radiographic equipment
CommitteeCH/62/3
ISBN978 0 539 10346 5
PublisherBSI
Pages0

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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