The Journal of Korean Medicine (대한한의학회지)

The Society of Korean Medicine (대한한의학회)
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A Study on Developing Safety and Performance Assessment Guideline for Electronic Warm-Acupuncture Apparatus

전기식 온침기에 대한 안전성 및 성능평가 가이드라인 개발 연구

  • Hansol Jang (Department of Internal Korean Medicine. Dongguk University Bundang Oriental Hospital ) ;
  • U-Ryeong Chung (Department of Internal Korean Medicine. Dongguk University Bundang Oriental Hospital ) ;
  • Jeong-Hyun Moon (Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital) ;
  • Seong-Kyeong Choi (Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital) ;
  • Won-Suk Sung (Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital) ;
  • Min-Seop Hwang (College of Korean Medicine, Dongguk University ) ;
  • Seung-Deok Lee (College of Korean Medicine, Dongguk University ) ;
  • Kyung-Ho Kim (Department of Acupuncture & Moxibustion, Dongguk University Ilsan Oriental Hospital) ;
  • Jong-Hwa Yoon (College of Korean Medicine, Dongguk University ) ;
  • Eun-Jung Kim (Department of Acupuncture & Moxibustion, Dongguk University Bundang Oriental Hospital)
  • 장한솔 (동국대학교 분당한방병원 한방내과) ;
  • 정우령 (동국대학교 분당한방병원 한방내과) ;
  • 문정현 (동국대학교 분당한방병원 침구과) ;
  • 최성경 (동국대학교 분당한방병원 침구과) ;
  • 성원석 (동국대학교 분당한방병원 침구과) ;
  • 황민섭 (동국대학교 한의과대학 ) ;
  • 이승덕 (동국대학교 한의과대학) ;
  • 김경호 (동국대학교 일산한방병원 침구과) ;
  • 윤종화 (동국대학교 한의과대학) ;
  • 김은정 (동국대학교 분당한방병원 침구과)
  • Received : 2022.07.29
  • Accepted : 2022.08.08
  • Published : 2022.09.01
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Abstract

Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

Keywords

References

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