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Evaluation Method of Portable Handheld U-healthcare Medical Devices
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휴대형 유헬스케어 의료기기 평가방법

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Type
Academic journal
Author
Myung-Hyun Nam (고려대학교) Soo-Chan Kim (국립한경대학교) Jang Su Kim (고려대학교) Kap No Lee (고려대학교) San Kim (식품의약품안전평가원) Ji Hun Cha (식품의약품안전평가원) Chan-Hoi Hur (식품의약품안전평가원) Ki-Jung Park (식품의약품안전평가원)
Journal
The Institute of Electronics and Information Engineers The Institute of Electronics Engineers of Korea - System and Control Vol.49-SC No.2 KCI Accredited Journals
Published
2012.3
Pages
55 - 62 (8page)

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Evaluation Method of Portable Handheld U-healthcare Medical Devices
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Convergence of information technology (IT) and medical devices enables people to measure health-related information ubiquitously, such as measuring blood glucose at home and checking cardiac signals during exercise and it allows us to access to medical care anywhere and anytime. Nowadays, the market for U-healthcare medical devices is growing rapidly, but guidelines for the evaluation of safety and effectiveness of such devices remain to be formulated. We performed a study on the development of safety and performance evaluation method for portable, hand-held, U-healthcare medical devices. We reviewed current guidelines and standards for home-health devices from the Korea Food and Drug Administration (KFDA) and related international committees such as the ISO/IEEE and CE. We summarized the test methods and items for the evaluation of safety and performance related to U-healthcare medical devices from the above guidelines and standards. We defined requirements for a U-healthcare medical device to demonstrate good performance. In conclusion, we propose an evaluation method for U-healthcare medical devices, which will help improve the safety and reliability of these devices.
#U-healthcare #Guidelines #Personal health device #ISO/IEEE #Convergence #Ubiquitous

Contents

요약
Abstract
Ⅰ. 서론
Ⅱ. 본론
III. 결론
참고문헌

References (10)

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1. [학술지(정기간행물)] - 곽연식 / 2000 / 보건의료정보 표준화의 국제동향 및 국내활동 / 대한의료정보학회지 6 (3) : 97 ~ 107 google schola 2. [기타자료] - 산업교육연구소 / 2009 / 2009 전자의료기기 및 u-Health 산업 총람 / 메디저널신문사 google schola 3. [보고서] - 강성욱 / 2007 / 유헬스케어(u-health)의 경제적 효과와 성장전략 google schola 4. [학술지(정기간행물)] - 오해석 / 2006 / U-헬스케어 기술 및 표준화 동향 / TTA journal dbpia 5. [인터넷자원] - / / http://www.fda.gov/downloads/MedicalDevices/Pr oductsandMedcalProcedures/HomeHealthandConsumer/HomeUseDevices/UCM209056.pdf google schola

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