• Journal of Pharmaceutical Investigation
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• 제39권2호
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• pp.127-131
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• 2009

Hydrogels for medical devices such as hydrophilic dressing, moisturizing healing band, hydrophilic intravenous catheter and soft contact lens were evaluated for their cytotoxicity according to the International Organization for Standardization (ISO) procedures. To test indirect cytotoxicity of hydrogel products, dissolution medium and dissolution condition were selected based on the guideline for medical devices. Cytotoxicity was low in all the case of hydrogel products. Soft contact lens showed no significant difference in dissolution between complete medium and saline. Currently, there is no specific guidelineto test hydrogel for medical devices in Korea with consideration of characteristics of hydrogel. Thus, proper method of cytotoxicity evaluation should be selected depending on the characteristics and usages of hydrogels for medical devices.

• 한국산학기술학회논문지
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• 제8권4호
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• pp.758-767
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• 2007

오늘날 의료기기는 내장된 소프트웨어에 의해 제어되는 전자 의료기기의 형태로 급격하게 발전하고 있다. 따라서 전자 의료기기의 품질은 내장된 의료용 소프트웨어의 품질에 의해 크게 좌우될 수밖에 없다. 특히, 의료기기가 인간의 생명과 밀접하게 연관되어 있다는 점을 고려할 때, 프로그램 가능한 전자 의료기기의 품질 측면에서도 신뢰성 측면을 특히 고려한 평가 방법이 연구되어야 할 것으로 생각된다. 본 논문에서는 소프트웨어 제품평가에 관련된 국제표준인 ISO/IEC 9126과 ISO/IEC 12119를 기반으로 하여 국내의 프로그램 가능한 전자 의료기기의 특성을 고려하여 신뢰성에 대한 평가를 위한 방법을 구축하고 아울러 신뢰성 평가 방법인 FMEA 기법을 적용할 수 있는 체계를 구축하였다.

• 한국임상수의학회지
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• 제32권1호
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• pp.85-90
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• 2015

In this study, we investigated the number of categories of veterinary medical devices registered by Animal and Plant Quarantine Agency (QIA) by 2013. We also analyzed the sales of the veterinary medical devices reported from Korea Animal Health Product Association (KAHPA) from 2011 to 2013. The registration rate of veterinary medical devices has sharply increased since 2008, and a total of 495 categories from 141 companies were registered by the end of 2013. The multi-frequency products registered for companion animals were ultrasound imaging system, x-ray system, microchip & reader, telemetry system transmitter, and hematology analyzer. The veterinary medical devices for farm animals include marker, artificial insemination catheter, injector, and ultrasound imaging system. Of these products, the multi-frequency products dominated on the veterinary medical devices market. The market size of 223 (45.0%) veterinary medical devices was estimated to be approximately 20.6 billion Won in 2013; the proportion of domestic products and imports was 56% to 44%; the proportion of domestic demand and export was 82% to 18%, respectively. This study suggested that the registration and sales of the veterinary medical devices have gradually increased as the demand of health care services got bigger in Korea.

• 대한영상의학회지
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• 제81권4호
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• pp.863-885
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• 2020

의료기구들이 발달하면서 복부 및 골반 내에 이식되거나 거치되는 의료기구들이 다양해졌다. 흔하게 사용되는 기구들의 영상의학 소견은 영상의학과 의사들에게 매우 익숙하지만, 상대적으로 사용 빈도가 낮거나 새로운 형태의 기구들의 영상의학 소견은 잘 알려져 있지 않다. 또한 환자에 대한 임상정보가 제한적일 경우 이런 새로운 형태의 의료기구들은 잘못 해석되거나 놓치기 쉽다. 그러므로 복부 및 골반 내 의료기구들의 영상의학 소견을 인지하는 것은 기구들의 올바른 위치를 평가하고, 이와 관련된 합병증을 평가하는데 있어 매우 중요하다. 본 논문에서는 다양한 복부 및 골반 내 의료기구들과 이와 관련된 합병증의 영상의학 소견을 소개하고자 한다.

• 문화기술의 융합
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• 제8권5호
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• pp.1-7
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• 2022

한국의 의료기기 산업은 1995년부터 시작된 G7 의료공학기술개발사업으로 본격적인 성장과 발전의 기틀을 마련하였으며 2020년 한국 의료기기 생산실적은 2001년에 비하여 8.52배, 수출 실적은 13.94배 성장하였다. 의료기기 국산화 개발 초기에 초음파 의료기기 등 전자 의료기기의 개발이 활발하였던 것과 비교하여 2020년에는 체외진단시약과 치과용 임플랜트의 생산 및 수출 실적이 상위권을 차지하고 있다. 그러나 한국 의료기기 시장에서 수입 의료기기가 차지하는 비중은 60-70%에서 큰 변화가 없는데 이는 한국의 의료기기 산업이 중저가 의료기기를 생산 수출하고, 기술집약적이고 자본집약적인 고가 의료기기는 주로 수입에 의존하고 있기 때문이다. 본 논문에서는 한국과 세계시장의 주요 의료기기 회사들의 생산 품목을 비교하여 한국 의료기기 산업의 세계 시장 진출에 대한 전략을 제시하고자 한다.

• 보건의료산업학회지
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• 제7권3호
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• pp.203-212
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• 2013

Medical devices separated by a committee of the International Electrotechnical Commission IEC TC (Technical Committee) 62 medical electrical equipment being promoted by the International standards. Actually, a lot of standards were existed, but many national and international standards for medical devices were lacking in practical standards that can be applied to their development. Most international standards were focused in electrical and mechanical safety of medical devices. Therefore, there were few practical standards which contain essential performance evaluation. Although medical device regulations do not enforce a fixed lifecycle model, activities are presented in a sequential manner, thus hinting at a waterfall process. Meanwhile, for a decade or more, software teams have benefitted from agile development methods. Several medical device manufacturers have adopted agile practices while keeping development in compliance with regulations, but conflicts arise and decisions have to be taken in favor of agility or formality. However, if there are new practical standards of medical devices, it must be possible to promote the medical devices industry in their nation. To do this, there is a need to develop a new standard could apply to the international market through the analysis of the medical device related technology. Consequently, new standards such as NP (New proposal) or NWIP (New Work Item Proposal) should be developed through international standardization of medical device technology.

• 전자공학회논문지
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• 제52권1호
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• pp.140-147
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• 2015

본 연구는 의료기기법이 시행된 이래 의료기기 부작용등 안전성 정보관리를 위한 의료기기 안전성 정보 원내 보고 시스템 설계에 대한 연구이다. 본 연구는 현행 의료기기 부작용등 안전성정보 보고 관리에 대한 법적 규정 및 시스템에 대한 절차와 현황을 파악하고, MSF/CD(Microsoft Solution Framework/Component Design)설계방법론을 적용한 시스템 설계 방법을 적용하여 의료기기 안전성 정보 원내 보고 시스템 구축을 위한 설계를 하였다. 본 연구를 통해 우리나라의 부작용 등 안전성 정보 보고에 대한 식품의약품안전처 고시 규정을 포함한 의료기기 관리 제도를 파악하고, 좀 더 환자의 안전과 의료기기의 위험관리를 효과적으로 할 수 있는 의료기기 안전성 정보 원내 보고 시스템을 설계 및 구축함으로써 의료기기 부작용 등 안전성 정보 보고의 활성화에 이바지 할 수 있기를 기대한다.

• Journal of Sport and Applied Science
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• 제1권1호
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• pp.1-5
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• 2017

Most of people do not remind of 'Who is domestic medical device business?' A lot of people that Johnson and Johnson, GE and Philips and other foreign companies belong to medical device company. In fact, local enterprises small place based on world market. Local medical device industry's production has grown up rapidly last 10 years. Sales increased nearly 3 times from trillion and 500 billion KRW in 2004 to 4 trillion and 600 billion KRW in 2014. The production record constantly increased owing to safety and good quality of domestic medical devices. As many as 59% of medical devices made in Korea is exported to 198 countries in the world. Currently, medical device industry in the world has been given considerable attention. Cognition and awareness are very much low. Medical device industry, high income creating industry, is said to next generation industry to increase scale, and Korea does not follow world flow. The industry is given support from the government that is not enough. Korean enterprises have small scale among a lot of global enterprises. Being interested in development of medical devices, the author selected department of IT at college.

• 대한치과의사협회지
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• 제56권9호
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• pp.479-490
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• 2018

3D printing technology supporting the specific patient medical services is actively being implemented in dentistry. The purpose of this study is to introduce the legal and institutional considerations to the medical practitioners in dentistry who must observe when they manufacture medical devices using 3D printers, and to provide a ways to activate and enhance their utilization in the domestic approval point of view for medical devices. Through the public data of government agencies and related organizations, the statutory system and compliance matters related to the manufacture of 3D printing medical devices have been examined and reviewed for the government's improvement efforts. Through the study, the government has been actively improving the system and making policy, but the active interest and participation of medical professionals and related workers are continually required to solve the problems which are scattered. 3D printing technology is expected to be more frequently utilized in the field of dentistry in near future. Therefore, it is essential to establish measures to improve the regulation through continuous cooperation with the related ministries with the long-term point of view enhancing smooth entry to the market for the medical devices by taking data from the continued research.

• 대한의용생체공학회:의공학회지
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• 제41권6호
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• pp.256-263
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• 2020

The importance of quality control has been emphasized to maintain safety of patients and satisfaction of medical service with medical devices used in clinic. Accordingly, objective evaluation method and standards consistently has been brought up for demand to replace outdated medical devices in appropriate time and to maintain the quality of medical service. Though many studies made suggestions methods to determine what medical devices to be replaced first, these methods were difficult in practice for its complex evaluation criteria and long time to evaluate. Therefore, in this study, a simple evaluation method is developed to identify and prioritize medical devices that are ought to be replaced. For the development of this simple evaluation method, four major characteristics of technology, safety, finance, and user satisfaction, which are considered in clinics to evaluate medical device replacement, and 14 minor attributes are distinctively selected. Each characteristic is assessed in binary form of "YES" or "NO" to minimize its subjective nature. Using this method to evaluate sampled medical devices belonging to four different characteristics, devices are suggested to be replaced in the current financial year or in the following financial year, or re-evaluated by the end of this financial year. Such results of evaluation can amend the subjective nature of existing evaluation method and give objective standards more promptly.