IEC 60601-2-11 Gamma Beam Therapy Equipment Testing
Medical electrical equipment – Part 2-11: the basic safety and essential performance of gamma beam therapy equipment
IEC 60601-2-11 Introduction:
The use of gamma beam therapy equipment for radiotherapy purposes may expose patients to danger if the medical electronic equipment fails to deliver the required dose to the patient, or if the medical electronic equipment design does not satisfy standards of electrical and mechanical safety. The medical electronic equipment may also cause danger to persons in the vicinity if the medical electronic equipment itself fails to contain the radiation adequately or if there are inadequacies in the design of the treatment room.
IEC 60601 2 11 and EN 60601 2 11 testing establishes requirements to be complied with by manufacturers in the design and construction of gamma beam therapy equipment. Sub-clause 201.10.2 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.
Sub-clause 201.10.2 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 medical electronic equipment. It places limits on the degradation of medical electronic 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 of the medical electronic equipment.
It should be understood that, before installation, a manufacturer can provide a compliance certificate relating only to type tests. Data available from site tests should be incorporated in the accompanying documents, in the form of a site test report, by those who test the medical electronic equipment after installation.
Keystone Compliance assists manufacturers with IEC 60601-2-11 and EN 60601-2-11 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-11 test lab needs.