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A Base Study on the Constancy Quality Control Test and Clause of Diagnosis Radiation Equipment

진단용 방사선 발생장치의 수시 정도관리 항목 및 기준에 관한 기초 연구

  • Heo, Yeji (Dept. of Biomedical Engineering, Inje University) ;
  • Kim, Kyotae (Dept. of Hybrid Medicine and Science, Inje University) ;
  • Noh, Sicheul (Dept. of Radiological Science, International University of Korea) ;
  • Nam, Sanghee (Dept. of Biomedical Engineering, Inje University) ;
  • Park, Jikoon (Dept. of Radiological Science, International University of Korea)
  • Received : 2014.03.16
  • Accepted : 2014.04.25
  • Published : 2014.04.30

Abstract

Diagnostic radiation equipment diagnosis and treatment of disease of recent plays a central role, but this is based on the assumption of an appropriate balance of benefits and risks of diagnostic. If balance is not maintained has the potential to give an adverse effect on the health of the public. In the case of an overseas, the importance of (QA) quality assurance of medical equipment is growing, but evaluation criteria of quality assurance has not been clearly presented in domestic. Therefore, the modernization of medical equipment from the point at which the degree of cycle-by-cycle management system of foreign national to be suitable for diagnostic radiation generator entry and quality control standards by introducing a tailoring is necessary. In this study the most frequently used diagnostic radiation generator X-ray imaging apparatus of the general three-year periodic inspections at any time between the periodic inspection items and quality control methods and standards for the establishment of the United States, Canada and abroad, and international electronic literature search Technical Committee (International Electro-technical Commission, IEC) were compared with the provisions of item. Based on the national quality control items when opening frequent inspection items and standards presented as a basis for setting up study.

국내 진단용 방사선 발생장치는 3년 주기로 시행되는 정기적인 정도관리 검사에 앞서 일별, 주별, 월별, 분기 반기별로 시행하는 수시 정도 관리에 대한 항목 및 규정이 명확하게 지정되어 있지 않다. 미국과 유럽 등의 선진국에서는 정도 관리 항목에 대해 검사를 수행하는 검사자를 구분하여 국가 기관에 보고하도록 되어 있으므로 체계적인 검사 수행과 더불어 검토가 가능하다. 그러므로 의료 장비의 현대화가 이루어지는 시점에서 국외의 주기별 정도관리 시스템을 국내 진단용 방사선 발생 장치에 적합하도록 도입하여 정도관리 항목과 기준의 재정립이 반드시 필요하다. 이에 본 논문에서는 진단용 방사선 발생장치 중 가장 빈번히 사용되고 있는 일반 X선 촬영 장치의 3년 정기점검 사이에 주기적인 수시 정도 관리 검사 항목과 방법 및 기준 수립을 위해 미국, 캐나다 등의 국외 문헌 조사 및 국제 전자 기술 위원회(International Electro-technical Commission, IEC)의 규정 항목과 비교하였다. 이를 바탕으로 국내 수시 정도관리 항목 신설 시 필요한 검사 항목 및 기준 설정을 위한 기초 자료로 제시하고자 하였다.

Keywords

References

  1. Kyo Tae Kim, et al., "A Study on the Improvement of Evaluation Methods and Standards for Simulation evaluation of Computed Tomography", The Korean Society of Radiology, Vol 7, No 5, pp. 339-345, 2013. https://doi.org/10.7742/jksr.2013.7.5.339
  2. Korea Testing Laboratory, "A study on the mandatory application plan for the third edition of IEC 60601 standards series(General Standard, Collateral Standards, Particular Standards)", National Institute of Food and Drug Safety Evaluation, 2011.
  3. Safety management of Diagnostic radiation generator rules, Inspection criteria for diagnosis of radiation devices-Article, Vol. 4, No. 1, Medical law Article 37.
  4. Sang Won Jo, Seon Hyeong Choi, etc, "A study on the improvement of safety testing standards and methods for mammpgraphy", Original Article, J Korean Soc radiol., Vol. 67, No. 6, pp. 451-459, 2012. https://doi.org/10.3348/jksr.2012.67.6.451
  5. Choi In Seok, Kim jyung Min, etc, "The recent trend of the national and international standard of manufacturing quality control for diagnostic X-ray equipment", Radiation Technology and Science, Vol. 32, No. 1, 2009.
  6. Agency for Technology and Knowledge Economy, "Evaluation and routine testing in medical imaging departments - Part 2-11: Constancy tests - Equipment for general direct radiography", 2005.
  7. 21 CFR 1030 : Performance standards for microwave and radiation frequency emitting products.
  8. "Diagnostic X-ray Unit QC Standards In BC", Radiation Protdction Services, 2004.
  9. "Quality Assurance in Diagnostic Radiology - Report of the Sub - Committee on Standards to Radiation Protection Setvice", John Aldrich, 2000.
  10. Devision of radiation safety and medical products, "A study on guidance for test and method of medical radiation", Food and Drug Administration, 2011.

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