• 대한의사협회지
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• 제61권12호
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• pp.702-705
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• 2018

Advances in technology lead to advances in medical devices, and these advances have the positive effect of creating opportunities for beneficial developments in healthcare, such as innovating traditional healthcare processes or expanding opportunities for diagnosing and treating diseases. Nonetheless, device developers, suppliers, users, insurers, and patients all face the challenge of balancing patient safety and health effectiveness with a reasonable profit. In Korea, the New Health Technology Assessment system aims to introduce safe and effective health technology, but this is only effective for the entry of devices onto the healthcare market. This system is not enough for creating a healthy ecosystem in which high-quality technologies and devices survive in the market and naturally exit from the market if not successful. The nation must not lag in the rapid development of medical devices, but the concomitant requirement for patient safety is like two rabbits moving in different directions. There is not enough time to resolve each source of uncertainty for both developers and users. The early adoption of health technologies, including medical devices, offers new opportunities for treatment and diagnosis, but also poses unexpected health risks. Thus, we need to design a plan to generate scientific evidence related to medical devices after they introduced into practice. Additionally, regarding the use of individual medical devices, we believe that the creation of a healthy ecosystem for medical devices by implementing medical device surveillance culture is a way to manage the opportunities and risks of the early introduction of innovative medical devices.

• 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.

• International journal of advanced smart convergence
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• 제8권3호
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• pp.87-94
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• 2019

IoT-based services are being released in accordance with the aging population and the demand for well-being pursuit needs. In addition to medical device companies, companies with ideas ranging from global ICT companies to startup companies are accelerating their market entry. The areas where these services are most commonly applied are health/medical, life/safety, city/energy, automotive and transportation. Furthermore, by expanding IoT technology convergence into the area of life care services, it contributes greatly to the development of service models in the public sector. It also provides an important opportunity for IoT-related companies to open up new markets. By addressing the problems of life care services that are still insufficient. We are providing opportunities to pursue the common interests of both users and workers and improve the quality of life. In order to establish IoT-based digital life care services, it is necessary to develop convergence technologies using cloud computing systems, big data analytics, medical information, and smart healthcare infrastructure.

• 한국신뢰성학회지:신뢰성응용연구
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• 제15권1호
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• pp.27-32
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• 2015

Functional safety is part of the overall safety relating to the equipment under control (EUC) and the EUC control system that depends on the correct functioning of the electrical/electronic/programmable electronic (E/E/PE) safety-related systems. Since the complexity of the medical equipment is increased, manufactures have to obtain functional safety as well as basic safety. This study proposes a perspective for applying functional safety to medical equipment. The research is carried out with respect to overall safety life-cycle of functional safety and essential performance of the medical equipment. The relationship between functional safety and essential performance is identified centered on the safety function. The essential performance using E/E/PE systems is defined as a safety function of functional safety. This approach is applied to a ultrasound imaging system as a case study.

• 대한수의학회지
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• 제57권2호
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• pp.71-78
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• 2017

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.

• 인터넷정보학회논문지
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• 제20권3호
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• pp.69-75
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• 2019

The safety and performance of medical device software is managed through life-cycle processes, which represent the entire process of research and development (R&D). The life-cycle process of medical device software is represented by an international standard called IEC 62304, ISO/IEC 12207. In order to license the product, the manufacturer must have document artifacts that comply with the IEC 62304 standard. However, these standards only describe the content of the activity and do not provide a method or procedure for documentation. Therefore, this paper suggests R&D documentation guidelines that assist medical device software developers to have R&D documents conforming to the standards. For this purpose, this study identifies the requirements related to documentation among the requirements existing in the standard and extracts them in the form of guidelines showing only the core information of the requirements. In addition, through the Web framework implemented based on this research, the developer can evaluate whether the technical documents are written in accordance with the R&D document guidelines. Medical device software manufacturers can efficiently produce high-quality research and development documents through R&D documentation guidelines, and they can have standards-compliantresearch and development documentation required for licensing procedures.

• 한국응급구조학회지
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• 제26권1호
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• pp.87-99
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• 2022

Purpose: This study aimed to provide basic data for the improvement of the standards related to the performance improvement of the firefighting equipment standards for special ambulances. Methods: Among the domestic firefighting equipment standards, the special ambulance standard was compared with the NFPA 1917 standard for the United States automobile ambulance 2019 and European Union European standard EN 1789 medical vehicle and its equipment, a road ambulance. Results: Anti-skid performance based on indoor noise standards, performance standards for interior lights, seat belt warning device, child car seat fixing device, safety handle, auxiliary footrest, and flooring materials should be supplemented. Conclusion: It is necessary to strengthen the production and performance standards for improvement to a level corresponding to the national standards, such as the United States and European Union.

• 대한의용생체공학회:의공학회지
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• 제32권2호
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• pp.151-157
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• 2011

Tattooing is a performance for decorative and cosmetic marking by placing permanent ink into the skin. As the cultural meaning of tattoo in Korea is changing, the tattoo machines are widely spread n permanent cosmetic market. Though the use of the tattoo machine was increased, the evaluation standards of tattoo machine were not existed. Korea Food and Drug Association regulated the electrical and mechanical safety standards which were founded on the IEC 601-1 second edition. Also they regulated he biological safety standards which were derived from the ISO 10993 series, however, these general valuations of common medical device were insufficient for evaluating tattoo machine. We developed the standards of tattoo machine for safety and performance evaluation for tattoo machine by preliminary hazard analysis in ISO 14971. The evaluation criteria of tattoo machines are focused on the mechanical invasion. We suggested the additional evaluation items of the needle speed, length, vibration with general valuation criteria of common medical device. We anticipate that this research may be a primary stage to figure a standard regulation and evaluation for tattoo machine.

• 한국표면공학회지
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• 제57권4호
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• pp.234-253
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• 2024

As the population ages, the importance of effective bone disease treatments is increasing, highlighting the role of bone grafts. Bone grafts are categorized into natural (autografts, allografts, xenografts) and synthetic (ceramics, polymers). Natural grafts have excellent regenerative abilities but pose biological risks, while synthetic grafts are biocompatible but less effective in regeneration. Various studies aim to enhance the safety and efficacy of bone grafts, significantly altering their surface properties. This review examines these studies and the resulting surface changes, aiming to guide future research and clinical applications.

• 전자공학회논문지SC
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• 제49권2호
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• pp.55-62
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• 2012

정보기술과 의료기기의 융합에 의해 혈당을 집에서 측정하거나 운동 시에 심박수를 측정하는 것과 같이 건강관련 정보를 언제 어디서나 측정할 수 있게 되었고, 이에 따라 의료를 장소에 구애받지 않고 쉽게 접근할 수 있게 되었다. 최근에 유헬스케어 의료기기 시장이 빠르게 성장하고 있으나 이러한 기기의 안전성과 유효성을 평가하는 가이드라인이 아직 마련되지 않은 실정이다. 이를 위해 식약청, ISO/IEEE, CE 등 국내외의 유헬스케어 관련 규정을 조사하고, 이 중 유헬스케어 의료기기에 관련된 안정성 및 성능 평가에 대한 시험 방법과 항목을 제안하였다. 유헬스케어 의료기기의 가장 큰 특성인 무선 데이터 통신에 있어 데이터 무결성과 기기 사용환경이 다양하기 때문에 환경 요인이 기기에 미치는 영향을 평가하였다. 이를 바탕으로 휴대형 유헬스케어 의료기기의 평가 가이드라인을 제안하였다. 제안하는 지침을 기반으로 휴대형 유헬스케어 기기를 개발한다면 사용자들에게 보다 안전성과 신뢰도 높은 기기를 제공할 수 있을 것으로 기대된다.