IEC 60601-2-8 Therapeutic X-Ray Equipment Testing
Medical electrical equipment – Part 2-8: the basic safety and essential performance of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
IEC 60601-2-8 Introduction:
X-ray equipment for radiotherapy purposes is used for teletherapy, where the radiation source is far from the tissues to the treated (usually more than 50 cm), and also for brachytherapy, where the radiation source is positioned within or adjacent to the tissue to be treated. IEC 60601 2 8 and EN 60601 2 8 testing covers X-ray equipment for both teletherapy and brachytherapy.
The use of X-ray equipment for radiotherapy purposes may expose the patient to danger if the equipment fails to deliver the required dose to the patient, or if the equipment design does not satisfy standards of electrical and mechanical safety. The equipment may also cause danger to persons in the vicinity if the equipment itself fails to contain the radiation adequately and/or if there are inadequacies in the design of the treatment room.
IEC 60601-2-8 testing establishes requirements to be complied with by the manufacturers in the design and construction of therapeutic X-ray equipment. Sub-clause 201.10.1 contains limits beyond which interlocks prevent, interrupt or terminate irradiation in order to avoid an unsafe condition.
Sub-clause 201.10.1 does not attempt to define optimum performance requirements. Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such equipment. It places limits on the degradation of equipment performance beyond which it can be presumed that a fault condition exists, e.g. a component failure, and where an interlock then operates to prevent continued operation of the 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 equipment at installation.
Keystone Compliance assists manufacturers with IEC 60601-2-8 and EN 60601-2-8 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-2-8 test lab needs.