Software validation for refurbished nuclear equipment

Software validation is an important tool used to assume the quality of device software, software automated operation and software for self diagnostics. Software validation can increase the usability and reliability of the devises, resulting in decreased failure rate, fewer recalls and correction action, less risk to user and patients for medical devises, reduce long term costs by making it easier and less costly to reliably modify software and revalidate software changes. In recent years a large number of nuclear equipment were refurbished at the nuclear refurbishing laboratory of Bangladesh Atomic Energy commission. The equipments are thyroid uptake system, probe renogram, gamma cameras and RIA counter. All these were tested for QA/QC according to IAEA protocol. Beyond the IAEA TECDOC 602 software validation tests were performed. Software for all these equipment were classified into three categories, such as self test, calibration and setup, data collection from the sensor and finally the analysis software like activity in a specific volume, blood flow, image reconstruction and processing etc. All refurbished equipment before going to use for medical purposes it was decided to test the developed software as a part of validation check. As the software module of each component is different especially for medical equipment, total test volume is very high. For a single equipment like gamma camera a large number of protocols presents for diagnosis in addition to hard ware control, calibration, quality control auto peak detection and positioning etc. To reduce the volume of tests for refurbished equipment special selection procedure were applied on the basic of hardware replacement. It was observed that replacement of high speed hardware, the equipment have generated the same result as the original ones does. Due to absence of references data, original position of each equipment could not be assessed after refurbishment. (author)