• Journal of the Korean Society of Radiology
• /
• v.8 no.7
• /
• pp.467-477
• /
• 2014

The purpose of this study is to offer data base for establishment of dental training x-ray generator based safety usage through surveying real radiation safety management state of radiation worker's in plan of operations that have dental training x-ray generators and use it. For it, comprehensive references were surveyed referring reports of current state of regulation technique development and domestic radiation safety evaluation and nuclear related legislation regarding radiation safety management of dental training x-ray generators. On the basis of it, questionnaires were filled in about respondent's general characteristic radiation safety manager's status current state of radiation safety management and the level of knowledge & consciousness. For the study, the survey was conducted to 224 people of radiation safety managers and university graduates training assistants and full-time professors who can treat dental training x-ray generators in education center. through this survey 95 questionnaires were used as analysis materials except the insufficient and omitted responses. As a method of analysis, the frequency and percentage were figured out with the general characteristics and safety manager's status. Chi-square test for frequency and correlation per question analysis and Pearson correlation analysis for crosslevel correlation were done with current state of radiation safety management and knowledge & consciousness level. As a result, running dental training x-ray generators was dealt with by 20's to 40's who have high education level over post undergraduate degree and major in dental hygienic. In addition, female have higher consciousness level for radiation safety management than male. It shows significal linear relation statistically(${\chi}^2$ >5, 0.1${\chi}^2$ >5, 0.3${\chi}^2$ >5, 0.3

• Journal of radiological science and technology
• /
• v.39 no.4
• /
• pp.651-660
• /
• 2016

Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.