Journal of radiological science and technology (대한방사선기술학회지:방사선기술과학)

Korean Society of Radiological Science (대한방사선과학회)
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Amendment of the Inspection Standard for Diagnostic Radiation Equipment Applying IEC 60601-1-3: Medical Electrical Equipment - Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment

KS C IEC60601-1-3: 의료용 전기기기-제1-3부: 기본 안전 및 필수 성능에 관한 일반 요구사항-보조표준: 진단용 X선 장치의 방사선 방어를 적용한 진단용 방사선 발생장치의 검사기준 개선안

  • Park, Hye-Min (Department of Bio-convergence Engineering, Korea University) ;
  • Kim, Jung-Min (School of Health and Environmental Sciences, Korea University) ;
  • Kim, Jung-Su (Department of Radiologic Technology, Chungbuk Health & Science University) ;
  • Kim, Seong-Ok (Korea Institute of Testing & Examination) ;
  • Choi, Young-Min (Korea Institute of Medical Device Assessment)
  • 박혜민 (고려대학교 바이오융합공학과) ;
  • 김정민 (고려대학교 보건환경융합과학부) ;
  • 김정수 (충북보건과학대학교 방사선학과) ;
  • 김성옥 ((재)한국의료기기검사원부설 방사선안전검사원) ;
  • 최영민 ((재)한국의료기기평가원)
  • Received : 2018.08.14
  • Accepted : 2018.10.24
  • Published : 2018.10.31
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Abstract

The diagnostic radiation equipment is managed in accordance with the "Rules for Safety Management of Diagnostic Radiation Equipment" enacted in 1995. The equipments should be inspected before use and every three years after use in accordance with the [Appendix 1] of the same rule. The inspection standard has been maintained without particular revision since enacted. But, over the past two decades new types of equipments have been manufactured and used. So, it is necessary to revise [Appendix 1] by making inspection items and inspection standards. In this study, we revised the classification system of equipments and reviewed international standards of IEC 60601 series, IEC 61223 series and AAPM TG 18 On-line Report No.03. And identified the problem of current inspection standards. Through this, we revised, deleted and added the inspection items and inspection standard of each equipment to meet the domestic circumstances. As a result of the study, we reorganized the classification system of equipment which are current classified as 5 classes into 22 classes as X-ray system etc. (7 classes), CT system etc. (5 classes) and Dental X-ray system etc. (10 classes). And then, we developed 70 inspection items for 6 types of equipments according to the reorganized classification system of equipments. The inspection items and inspection standards derived from this study have been proposed to the KCDC and will be applied to the revision of the Rule's [Appendix 1]. Therefore, we expect to be used as reference materials for domestic medical center, inspection institutions, and equipment manufacturing import companies.

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References

  1. International Commission on Radiological Protection ICRP publication 117 Radiological Protection in Fluoroscopically Guided Procedure outside the Imaging Department. The Korean Association for Radiation Protection. 2010.
  2. Ministry of Health & Welfare. Medical Service Act Article 37 (Radiation Generator for Diagnosis). 2016.
  3. Ministry of Health & Welfare. Rules for Safety Management of Diagnostic Radiation Equipment. 2017.
  4. Kim HJ, Lee JE, Lee BY, Park YJ, Kim HJ, Song SK, et al. Safety Management Present condition of Diagnostic Radiation Generator in 2016. The Korean Association for Radiation Protection. Collection of a conference paper. 2017:304-305.
  5. Ministry of Food and Drug Safety Notification. Regulations on the classification of medical devices and grade. 2018.
  6. International Electrotechnical Commission IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2012.
  7. International Electrotechnical Commission IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment. 2013.
  8. International Electrotechnical Commission IEC 60601-2-44:2009+AMD2:2016 CSV Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography. 2016.
  9. International Electrotechnical Commission IEC 60601-2-45:2011+AMD1:2015 CSV Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. 2015.
  10. International Electrotechnical Commission IEC 60601-2-45:2011+AMD1:2015 CSV Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices. 2015.
  11. International Electrotechnical Commission IEC 60601-2-54:2009+AMD1:2015 CSV Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. 2015.
  12. International Electrotechnical Commission IEC 60601-2-63:2012 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extraoral X-ray equipment. 2012.
  13. International Electrotechnical Commission IEC 60601-2-65:2012 Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental intraoral X-ray equipment. 2012.
  14. International Electrotechnical Commission IEC 61223-2-6:2006 Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy test - Imaging performance of computed tomography X-ray equipment. 2006.
  15. International Electrotechnical Commission IEC 61223-2-11:1999(Withdrawn) Evaluation and routine testing in medical imaging departments - Part 2-11: Constancy test - Equipment for general direct radiography. 1999.
  16. International Electrotechnical Commission IEC 61223-3-5:2004 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment. 2004.
  17. American Association of Physicists in Medicine. AAMP On-line Report No.03, Assessment of Display Performance for Medical Imaging Systems, American Association of Physicists in Medicine Task Group 18 Imaging Informatics Subcommittee. 2005.
  18. Kim HJ, Kim JM, Choi IS, Yoon YS, Seo DN, Kim JS, et al. Features and Trends of IEC Particular Standards for Medical Equipment Related to Diagnostic X-ray Based on IEC 60601-1:2005 Ed. 3.0. Journal of Radiological Science and Technology. 2013;36(1):1-10.
  19. Choi IS, Kim JM, Jeong HW, Min JW, Lee IS. The Recent Trend of the National and International Standard of Manufacturing Quality Control for Diagnostic X-ray Equipment. Journal of Radiological Science and Technology. 2009;32(1):1-15.
  20. Jung HR, Han BH, Hong DH. Testing and Analysis of Tube Voltage and Tube Current in The Radiation Generator for Mammography. Journal of Radiological Science and Technology. 2014;37(1):1-6.
  21. Cho CH. A study on the appropriateness through performance evaluation of diagnostic X-ray equipment. [master's thesis]. Daejeon: Eulji University; 2015.
  22. Kim JM, Kim SC, Ko SK. Radiation devices & management experiment. Seoul: Daihak Seorim Co. Ltd.; 2000.