Regarding "Evaluation and routine testing in medical imaging department"

Abstract

Quality Assurance of medical equipment has become important as the improvement of medical service and development. According to the International Standards (IEC), the evaluation of quality maintenance process and routine testing in medical imaging department has been standardized all the time, in Japan, in the form of JIS standardization. Here I would like to introduce the main standard "JIS Z4752-1 Evaluation and routine testing in medical imaging departments. Part-l: General Aspect" which will be standardized in 2001, on other circumstances/basic thinking pattern, and quality assurance process. The author attempted to propose in the style of "Responsibility of user and manufacturer" having been the member of IEC WG-10 (Quality Assurance) and "JIS Technical Committee" with full of historical backgrounds, stating relationships to the Federal Regulations of the United States. Acceptance Test and Constancy Test (Periodical Test) are specific processes of quality. Basically, the Acceptance Test is performed by both of user and manufacturer, and the Constancy Test is performed only by user. The standard is effective to gain reliability on handling medical disputes on evaluation of quality administration, routing testing, the equipment performance maintenance, safety, image quality, and minimum radiation dose