• 대한의용생체공학회:의공학회지
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• 제36권3호
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• pp.69-78
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• 2015

Ultrasonic physiotherapy systems should comply with IEC 60601-2-5(particular requirements for safety of ultrasonic physiotherapy equipment) standard for safety of patients and clinical performances. One of the most important parameters in the standard is the effective radiating area ($A_{ER}$). It has to be measured in accordance with IEC 61689 (field specifications and methods of measurement in the frequency range 0.5MHz to 5MHz). Typical ultrasonic physiotherapy system works in the frequency range 1MHz ~ 3MHz to comply with the IEC 61689. However, ultrasonic physiotherapy system using frequencies over 5MHz is out of the IEC 61689's scope. That is, even if such ultrasonic physiotherapy systems are developed by demands of the market, there is no standard to apply. It is the motivation for this study. Whereas there are other parameters to be considered, this study focuses on the effective radiating area and shows effectiveness of applying IEC 61689 in measuring effective radiating area of ultrasonic physiotherapy systems using frequency range over 5MHz by comparing the results of computer simulation and experiment. Results of this study shows that applying the IEC 61689 standard to ultrasonic physiotherapy system using frequency range over 5MHz is possible.

• Journal of International Society for Simulation Surgery
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• 제2권1호
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• pp.40-42
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• 2015

Purpose Usability is an important factor in our life. This paper presents an approach to design the clinical work-flow for ultrasound system. And, we tried to apply this work-flow in diagnosis ultrasound system. Materials and Methods For user learnability, we follow international standard IEC 60601-1-1 and IEC 62366 which describes usability of medical instrument. User requirement are applied by 10 clinicians who are well aware of usability. We considered user environment and designed clinical work-flow into two types: general use and emergency use. The designed clinical work-flow was evaluated by 10 clinicians and results derived from the evaluation were analyzed. Results We could successfully design optimized clinical workflow of ultrasound system. Conclusion This paper suggests usability testing for optimized ultrasound clinical workflow. Using this clinical work flow, users can enhance their clinical performance and reduce operation time.

• 대한방사선기술학회지:방사선기술과학
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• 제37권1호
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• pp.1-6
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• 2014

유방촬영용 방사선발생장치의 성능 관리 및 품질관리에 적용되는 관전압과 관전류량을 IEC(International Electrotechnical Commission; 국제 전기 기술위원회) 60601-2-45에서 제시한 표준을 근거로 시험하고 분석한 결과 다음과 같은 결론을 얻었다. 관전압에 따른 제조년도별 표준편차 값은 2001~2010 사이에서 3.15로 가장 크게 나타났고, 관전류량에 따른 제조년도별 표준편차 값은 2000년 이전에서 6.38로 가장 크게 나타났으며, 2011년 이후에 제조된 장치에서는 PAE(Percent Average Error; 백분률표준오차)의 표준편차가 비교적 적게 나타났다. 이는 최근에 제조된 유방촬영용 방사선발생장치의 관전압과 관전류량이 정확한 성능을 유지하고 있음을 알 수 있다. 본 연구결과를 기초자료로 활용하여 유방촬영용 방사선발생장치의 성능 및 품질 관리를 유지하므로 현재 식품의약품안전청의 "진단용 방사선발생장치의 안전관리에 관한 규칙"에서 규정하고 있는 3년 검사주기 동안에 자가 점검으로 방사선발생장치의 방사선에 대한 안전성 확보와 사용하는 X선 장치의 성능을 일관성(constancy) 있게 유지하도록 함으로서 궁극적으로 방사선에 대한 국민피폭선량을 줄일 수 있는 기대효과가 있을 것으로 기대된다.

• Journal of Acupuncture Research
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• 제32권4호
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• pp.91-102
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• 2015

Objectives : The Oriental medical device industry is expected to continue to experience significant growth. It should increase its global market share rather than focusing on the domestic market. Countries around the world self-regulate their domestic market, so this study aims to aid in the development of a particular overseas market by introducing the U.S.(the largest market) medical device registration and approval process. Methods : For an understanding of the US medical device licensing process, we researched the relevant regulatory organization (FDA), the history, definition and classification of medical devices, the approval and 510(k) submission process related to substantial equivalence, IEC 60601-1 Edition 3, usability tests, and so on. Results : Medical devices in the United States are assigned to one of three regulatory classes: Class I, Class II and Class III, based on the level of control necessary to assure the safety and effectiveness of the device. If a company's device is classified as Class II and if it is not exempt, a 510k will be required for marketing. 1) A 510(k) is a premarket submission made to the FDA to demonstrate that the new device to be marketed is "substantially equivalent" to a legally marketed device (predicate device) 2) The IEC 60601-1 Edition 3 preparation process, which contains information related to usability, is expensive and time-consuming but a critical requirement. Conclusions : Although the U.S. market has high barriers to entry, access to this, large overseas market will encourage development of the Oriental medical device industry and commercial value enhancement is expected.

• 대한방사선기술학회지:방사선기술과학
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• 제33권3호
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• pp.245-252
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• 2010

본 연구는 주제인 폴리우레탄(polyurethane, PU)과 새로운 형태의 n-type 산란재를 사용하여 합성한 조직모사물질(tissue mimicking materials : TMM)에 대해 국제표준규격 IEC 60601-2-37(2007)의 Annex D.D가 권고한 인체 연조직(soft tissue)의 음향학적 특성 기준에 준해, 전파속도, 임피던스, 감쇠계수 특성 등을 분석하였으며, 영상특성은 SONOACE 9900C PRIME(MEDESON Co.), 3.5 MHz 컨벡스 프로브(2.5-5.0 MHz)로 초음파 휘도와 최대투과심도를 분석 평가하여 다음과 같은 결론을 얻었다. 주제인 prepolymer와 polyol mixture를 혼합하고 n-type 산란재를 0~8%로 점차 증가하여 합성하였을 때, 1. 조직모사물질의 전파속도는 산란재가 증가할수록 연조직에 더 가깝게 수렴(convergence)하였다. 2. 음향임피던스는 산란재가 감소할수록 연조직에 더 가깝게 수렴하였다. 3. 감쇠계수는 산란재가 증가할수록 증가하였다. 4. 영상 평균휘도는 산란재가 증가할수록 증가하였으나 역치가 있었다. 5. 최대투과심도는 산란재 6% 조직모사물질에서 연조직에 가깝게 수렴하였다.

• 대한의용생체공학회:의공학회지
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• 제44권3호
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• pp.190-203
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• 2023

The purpose of this study is to provide basic data to ensure the safety and essential performance of a Lower Extremity robotic assisted gait training system and to provide advanced technology and technical basis to the industry handling the system. Based on IEC 60601-1:2012/AMD2:2020 (Medical Electrical Equipment - General requirements for basic safety and essential performance of medical electrical equipment), IEC 62366-1:2015/AMD1:2020 (Medical devices - Part 1: Application of usability engineering to medical devices) and EN ISO 14971:2019 (Medical devices - Application of risk management to medical devices), the requirements for ensuring the safety and essential performance of the Lower Extremity robotic assisted gait training system were derived. Through the Delphi survey method and scenario analysis, which reflects the opinions and knowledge of experts in the fields of development, testing and review of technical documents, and quality assurance of medical devices, validity and reliability were conducted and obtained results with adequate content validity ratio (CVR; 0.7≤) and excellent reliability (Cronbach's α; 0.9≤). As a result, it was confirmed that the reliability and validity of the risk management process to ensure the safety and essential performance of the Lower Extremity robotic assisted gait training system are required a model can be established to provide measures to reduce risks according to the level of risk exposure caused by usage.

• 대한방사선기술학회지:방사선기술과학
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• 제39권3호
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• pp.435-441
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• 2016

현재 시중에 설치되어 있는 의료용 X선 장치는 선량표시를 할 때 일반적으로 DAP(Dose Area Product) meter를 부착한다. 그러나 DAP meter가 전부 수입에 의존하고 있기 때문에 고가의 설치 비용 등의 문제가 있다. 본 연구에서는 서울시의 지원을 받아 순수 국산기술의 DAP meter 프로토타입을 제작하였고, 이 프로토타입의 성능을 독일산 I사의 제품과 비교하여 평가하였다. 평가 항목은 전자포집효율, 선량의존성, 선질의존성, 재현성, 자체흡수율, 광투과율 6개 항목으로 IEC 60580를 평가 기준으로 삼았다. 평가 결과 전자포집효율이 고유오차 9.5%, 선량의존성이 선형성 99%, 재현성이 변동계수 2%, 자체흡수율이 9%로 각각 합격기준을 만족시켰으나, 선질의존성이 변동한계 29%, 광투과율이 55%로 합격기준에 미달하였다. 아직 프로토타입이기에 앞으로 개선될 여지가 많다. 회로부터 재료까지 국산기술로 개발하고 있기 때문에 합격 기준에 미달하는 항목은 추후 해결 가능할 것으로 사료된다.

• 대한의용생체공학회:의공학회지
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• 제40권5호
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• pp.215-221
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• 2019

The respiratory medical device is a medical device that delivers optimal oxygen or a certain amount of humidification to a patient by delivering artificial respiration to a patient through a machine when the patient has lost the ability to breathe spontaneously. These include respirators for use in chronic obstructive pulmonary disease and anesthesia or emergency situations, and positive airway pressure devices for treating sleep apnea, and as the population of COPD (chronic obstructive pulmonary disease) and elderly people worldwide surge, the market for the respiratory medical devices it is getting bigger. As the demand for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, the boundaries between the items are blurred due to the purpose, intended use, and method of use overlapping similar items in a respiratory medical device. In addition, for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, in this study, we propose clear classification criteria for the respiratory medical devices according to the purpose, intended use, and method of use and provide safety and performance evaluation guidelines for those items to help quality control of the medical devices. And to contribute to the rapid regulating and improvement of public health. This study investigated the safety and performance test methods through the principles of the respiratory medical device, national and international standards, domestic and international licensing status, and related literature surveys. The results of this study are derived from the safety and performance test items in the individual ventilator(ISO 80601-2-72), the International Standard for positive airway pressure device (ISO 80601-2-70), The safety and performance of humidifiers (ISO 80601-2-74) and the safety evaluation items related to home healthcare environment (IEC 60601-1-11), In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers and importers, certified test inspection institutions, academia, etc., the final guidelines were established through revision and supplementation. Therefore, in this study, we propose guidelines for evaluating the safety and performance of the respiratory medical device in accordance with growing technology development.