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Standards Development
This document applies to X-ray image-guided radiotherapy equipment when used for therapy purposes in medical practice, and describes measurements and test procedures to be performed by the manufacturer of X-ray image-guided radiotherapy equipment.
It specifies test procedures for the determination and presentation of performance characteristics, knowledge of which is deemed necessary for proper selection, application, and use of X-ray image-guided radiotherapy equipment and which are to be declared in the accompanying documentation together with the deviation or variation to be expected under specific conditions in normal use.
The existing safety standard for X-IGRT(IEC 60601-2-68) only deals with basic safety and essential performance. This new work item proposal proposes test methods for the manufactures for reporting common characteristics to the responsible organization. This allows the responsible organization to compare different equipment and assists the responsible organization to establishing baseline quality assurance values.
It further includes Electronic Portal Imaging Device (EPID) when used for IGRT which is currently used in IEC 60977, to allow future updates and alignment of IEC 60976 to the latest edition of IEC 60601 -2-1.
It includes an informative Annex for guideline for functional performance characteristics guideline, and is similar in structure to medical light ion beam equipment - Performance characteristics (IEC 62667).
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