• Korean Journal of Veterinary Research
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• v.57 no.2
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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.

• Korean Journal of Artificial Intelligence
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• v.10 no.2
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• pp.13-18
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• 2022

The role of artificial medical intelligence through medical big data has been focused on data-based medical device business and medical service technology development in the field of diagnostic examination of the patient's current condition, clinical decision support, and patient monitoring and management. Recently, with the 4th Industrial Revolution, the medical field changed the medical treatment paradigm from the method of treatment based on the knowledge and experience of doctors in the past to the form of receiving the help of high-precision medical intelligence based on medical data. In addition, due to the spread of non-face-to-face treatment due to the COVID-19 pandemic, it is expected that the era of telemedicine, in which patients will be treated by doctors at home rather than hospitals, will soon come. It can be said that artificial medical intelligence plays a big role at the center of this paradigm shift in prevention-centered treatment rather than treatment. Based on big data, this paper analyzes the current status of artificial intelligence technology for chronic disease patients, market trends, and domestic and foreign company trends to predict the expected effect and future development direction of artificial intelligence technology for chronic disease patients. In addition, it is intended to present the necessity of developing digital therapeutics that can provide various medical services to chronically ill patients and serve as medical support to clinicians.

• Journal of Biomedical Engineering Research
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• v.43 no.4
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• pp.199-213
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• 2022

EN ISO 14971:2012 a risk management standard approved and applied as a European standard in 2012, will be adopted and applied as ISO 14971:2019 published in December 2019, ISO/TR 24971(Guidance) published in June 2020 from May 2022. After that, it is applied to IVDD surveillance and IVDR new and conversion, and the manufacturer is already preparing for application or is starting preparation for application. In addition, 98/78/EEC IVDD applied from 1998 will also be applied as REGULATION (EU) 2017/746 IVDR from May 2022. In particular, in IVDR, the requirements for post-marketing investigations such as Post Market Surveillance (PMS), Summary of safety and performance(SSP), Periodic Safety Update Report(PSUR) and Post Market Performance Follow Up(PMPF), which were not required in the existing IVDD, increased, and the contents were also specified. This study focused on ISO14971:2019 among these strengthened and newly applied regulations, and tried to present a detailed analysis and application plan of Post Market Surveillance (PMS) required by 2017/746 IVDR.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2010.10a
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• pp.762-763
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• 2010

The X-ray device used for medical treatment is classified into fixed type that is used by installing at the location with the stable power supply and mobile type that can be taken by moving the X-ray device to the location where a patient is. Mobile X-ray device which is typically used in the mobile type of X-ray can be used very usefully beyond the space restriction. However, due to its difficulty to generate high-voltage, it is mainly applied to take hand and foot shootings which only need low output power. In this study, by designing and producing the large volume of mobile X-ray device which doesn't have the limitations on diagnostic areas of the body, the operating characteristics of device according to the loading change was identified.

• Korean Journal of Materials Research
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• v.34 no.2
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• pp.63-71
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• 2024

Slipchip offers advantages such as high-throughout, low cost, and simple operation, and therefore, it is one of the technologies with the greatest potential for high-throughput, single-cell, and single-molecule analyses. Slipchip devices have achieved remarkable advances over the past decades, with its simplified molecular diagnostics gaining particular attention, especially during the COVID-19 pandemic and in various infectious diseases scenarios. Medical testing based on nucleic acid amplification in the Slipchip has become a promising alternative simple and rapid diagnostic tool in field situations. Herein, we present a comprehensive review of Slipchip device advances in molecular diagnostics, highlighting its use in digital recombinase polymerase amplification (RPA), loop-mediated isothermal amplification (LAMP), and polymerase chain reaction (PCR). Slipchip technology allows users to conduct reliable droplet transfers with high-throughput potential for single-cell and molecule analyses. This review explores the device's versatility in miniaturized and rapid molecular diagnostics. A complete Slipchip device can be operated without special equipment or skilled handling, and provides high-throughput results in minimum settings. This review focuses on recent developments and Slipchip device challenges that need to be addressed for further advancements in microfluidics technology.

• Journal of radiological science and technology
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• v.38 no.4
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• pp.389-394
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• 2015

There is a progressive development in the medical imaging technology, especially of descriptive capability for anatomical structure of human body thanks to advancement of information technology and medical devices. But however maintenance of correct posture is essential for the medical imaging checkup on the shoulder joint requiring rotation of the upper limb due to the complexity of human body. In the cases of MRI examination, long duration and fixed posture are critical, as failure to comply with them leads to minimal possibility of reproducibility only with the efforts of the examiner and will of the patient. Thus, this study aimed to develop an auxiliary device that enables rotation of the upper limb as well as fixing it at quantitative angles for medical imaging examination capable of providing diagnostic values. An auxiliary device has been developed based on the results of precedent studies, by designing a 3D model with the CATIA software, an engineering application, and producing it with the 3D printer. The printer is Objet350 Connex from Stratasys, and acrylonitrile- butadiene-styrene(ABS) is used as the material of the device. Dimensions are $120{\times}150{\times}190mm$, with the inner diameter of the handle being 125.9 mm. The auxiliary device has 4 components including the body (outside), handle (inside), fixture terminal and the connection part. The body and handle have the gap of 2.1 mm for smooth rotation, while the 360 degree of scales have been etched on the handle so that the angle required for observation may be recorded per patient for traceability and dual examination.

• Journal of the Korean Magnetics Society
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• v.16 no.4
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• pp.216-220
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• 2006

The electric signals for the voltage as a function of distance between Hall devices and permanent magnets over the radial artery were investigated. The electric sgnals, that means signals of arterial pulse wave, were differentiated by the hardware of circuits and then were changed to differential signals as magnetic field. The 3-D images simulated by the software as function fo the intensity of differential signals were achieved. It shows that these system can apply to pulse diagnostic apparatus of porthble type medical instrument.

• The Journal of the Korean dental association
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• v.55 no.11
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• pp.800-807
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• 2017

Ultrasonography is one of the most common diagnostic tools in medical imaging with non-invasive and non-radiation loaded characteristics. In the field of dentistry, especially for periodontology, high frequency ultrasonic device can be used for several purposes such as evaluating gingival thickness, identifying the level of alveolar bone, measuring the volume of mucosa of donor site for soft tissue graft and so on. According to recent studies, it was demonstrated that ultrasonic diagnosis had both accuracy and repeatability comparable to conventional diagnostic tools. However, improvement and development of intra-oral probe suitable for adpatation to gingiva and palatal mucosa, are considered as prerequisites for diffusion of ultrasonic diagnosis in periodontology.

• Journal of radiological science and technology
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• v.27 no.4
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• pp.37-41
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• 2004

Purpose : Raise ability cultivation in presence at a sicked business by performance management estimation of device through measurement. Also Learn a technology that measure exact tube voltage, exposure time, output dose. And it is to grasp photofluorography X-ray generator existing circumstances using at hospital. Material & Method : Investigated Photofluorography X-ray generator(inside, outside each 10) of 10 university hospitals using tube voltage, exposure time, output dose measuring instrument. Result : Photofluorography device that tube voltage correctness is incongruent by examination PAE decision came out 3, and at exposure time correctness examination 2 incongruent, Also 3 that calculate coefficient of variation about exposure in repeatability examination of exposure were incongruent. Inappropriate photofluorography device is 5 outside hospital(mobile unit) and the thing in hospital was 3 in 3 kind of efficiency test. It appeared high that photofluorography device outside hospital is more incongruent than thing in hospital. Conclusion : May ready situation that can offer patient medical service of good quality by radiation exposure reduction, image quality administration, retake decrease etc. by keeping performance of Photofluorography device. Therefore, is considered that need on-time efficiency test.

• Journal of Biomedical Engineering Research
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• v.44 no.3
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• pp.182-189
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• 2023

CT is a medical device that acquires medical images based on Attenuation coefficient of human organs related to X-rays. In addition, using this theory, it can acquire sagittal and coronal planes and 3D images of the human body. Then, CT is essential device for universal diagnostic test. But Exposure of CT scan is so high that it is regulated and managed with special medical equipment. As the special medical equipment, CT must implement quality control. In detail of quality control, Spatial resolution of existing phantom imaging tests, Contrast resolution and clinical image evaluation are qualitative tests. These tests are not objective, so the reliability of the CT undermine trust. Therefore, by applying an artificial intelligence classification model, we wanted to confirm the possibility of quantitative evaluation of the qualitative evaluation part of the phantom test. We used intelligence classification models (VGG19, DenseNet201, EfficientNet B2, inception_resnet_v2, ResNet50V2, and Xception). And the fine-tuning process used for learning was additionally performed. As a result, in all classification models, the accuracy of spatial resolution was 0.9562 or higher, the precision was 0.9535, the recall was 1, the loss value was 0.1774, and the learning time was from a maximum of 14 minutes to a minimum of 8 minutes and 10 seconds. Through the experimental results, it was concluded that the artificial intelligence model can be applied to CT implements quality control in spatial resolution and contrast resolution.