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http://dx.doi.org/10.13048/jkm.22037

A Study on Developing Safety and Performance Assessment Guideline for Electronic Warm-Acupuncture Apparatus  

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)
Publication Information
The Journal of Korean Medicine / v.43, no.3, 2022 , pp. 150-163 More about this Journal
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
Warm-Needle Acupuncture; Guideline; Medical Device Safety; Medical Device Design;
Citations & Related Records
Times Cited By KSCI : 10  (Citation Analysis)
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