IEC 60601-2-29:2008
Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
IEC 60601-2-29:2008 establishes requirements to be complied with by manufacturers in the design and construction of radiotherapy simulators; it does not attempt to define their 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 medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists, for example a component failure, and where an interlock then operates to prevent continued operation of the medical electrical equipment. This third edition cancels and replaces the second edition published in 1999. This edition constitutes a technical revision, which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.
IEC 60601-2-29:2008 establishes requirements to be complied with by manufacturers in the design and construction of radiotherapy simulators; it does not attempt to define their 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 medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists, for example a component failure, and where an interlock then operates to prevent continued operation of the medical electrical equipment. This third edition cancels and replaces the second edition published in 1999. This edition constitutes a technical revision, which brings this standard in line with the third edition of IEC 60601-1 and its collateral standards.
Applies to radiotherapy simulators: - that use diagnostic X-ray equipment to simulate physically a therapeutic radiation beam, so that the treatment volume to be subjected to irradiation during radiotherapy can be localized, and the position and size of the radiotherapy radiation field can be confirmed; - intended exclusively for radiotherapy simulation as a prelude to intended radiotherapy, and not for any other purpose such as general diagnostic examinations. Establishes requirements to ensure the ionizing radiation safety and enhanced mechanical and electrical safety of radiotherapy simulators; it identifies geometrical parameters that are critical for the accurate simulation of a radiotherapy treatment. Cancels and replaces the first edition published in 1993 and its amendment 1 (1996).
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