• Journal of Biomedical Engineering Research
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• v.36 no.5
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• pp.162-168
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• 2015

In this study, we suggested the performance and safety testing guideline for low intensity pulsed ultrasound (LIPUS) represented by the ultrasound fracture treatment device and cartilage treatment device and low intensity focused ultrasound (LIFU) represented by ultrasonic face lifting device. For these study, the international standards and management regulations of Korea, Japan and United State were analyzed. And the usefulness and applicability were evaluated by testing with commercial equipment and reflecting the views of the industry and experts. As a result of this study, the safety and performance test guidelines for low intensity therapeutic ultrasound device were proposed by presenting the 10 items for LIPUS and 12 items for LIFU. The suggested guidelines are considered a high utilization in the domestic testing and approval authorities. And they are also thought to be useful to new technology development.

• Journal of the Korea Safety Management & Science
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• v.17 no.1
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• pp.289-300
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• 2015

According to the generalization of mobile device use in our life, the complexity and diversity of mobile applications are increased, and thus the importance of application test to find faults and errors quickly and easily before release grows. This paper reviews the current automatic testing methodologies for mobile device applications and their element technologies. Also, well-known commercial tools for automatic testing are surveyed and case studies of their recent industry applications in domestic and foreign countries are performed.

• Journal of Applied Reliability
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• v.17 no.1
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• pp.50-57
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• 2017

Purpose : This paper is a comparative analysis results of the fatigue test for dental implants and accelerated life test by using a static type loading device commonly used in Korea and a dynamic type loading device (universal-joint) recommended by FDA. Methods : Fatigue tests of dental implant is based on ISO 14801 and classified into static load test and dynamic load test. The tests were carried out on three test specimens by four load stress steps under each loading device. For analysis on failure mode such as crack, fracture and permanent deformation of test specimens, we used X-ray three-dimensional computed tomography on test specimens before and after the fatigue tests. The design of the accelerated life test was based on the analysis results of the fatigue life data obtained from the dynamic load test and the statistical analysis software (Minitab ver.15) was used to analyze the appropriate life distribution. Results : As a result of the fatigue tests and the accelerated life tests at same acceleration condition under each test method, the fatigue life under the dynamic type loading device (universal-joint) was shorter than when static type loading device was applied. Conclusion : This paper can be used as a reference when the universal-joint type loading device for implants fatigue test is applied as ISO 14801.

• Proceedings of the Korean Institute of Information and Commucation Sciences Conference
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• 2012.10a
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• pp.495-497
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• 2012

Development of application risk management for medical device software test. First, Through questionnaires, Medical device manufacturers, Analysis of software validation and risk management status. Second, Analyzed by comparing the difference between black box testing and white box testing. Third, After analyzing the potential for software analysis tools using code derived factors were quantified, Finally, Medical device risk management process so that it can be applied to build the framework by FMEA(Failure Mode and Effect Analysis) technique. Through this Difficult to build software validation and risk management processes for manufacturers to take advantage of support in medical device GMP(Good Manufacture Practice).

• The Journal of Korean Academy of Prosthodontics
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• v.45 no.5
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• pp.687-695
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• 2007

Statement of problem: The proper contact relation between adjacent teeth in each arch plays an important role in the stability and maintenance of the integrity of the dental arches. Proximal contact has been defined as the area of a tooth that is in close association, connection, or touch with an adjacent tooth in the same arch. Purpose: The aim of this study was to develop a digital device for measuring the proximal tooth contact tightness by pulling a thin stainless steel strip (2mm wide, 0.03mm thick) inserted between proximal tooth contact. Material and method: This device consists of measuring part, sensor part, motor part and body part. The stainless steel strip was connected to a stain gauge. The strain gauge was designed to convert the frictional force into a compressive force. This compressive force was detected as a electrical signal and the electrical signal was digitalized by a A/D converter. The digital signals were displayed by a micro-processor. The pulling speed was 8mm/s. Results: For testing reliability of the device in vivo, two healthy young adults (A, B) participated in this experiment. The tightness of proximal tooth contact between the second premolar and the first molar of mandible (subject A) and maxilla (subject B) was measured fifteen times for three days at rest. We double-checked the accuracy of the device with a Universal Testing Machine. Output signals from the Universal Testing Machine and the measuring device were compared. Regression analysis showed high linearity between these two signals. In vivo test, no significant differences were found between measurements. Conclusion: This device has shown to he capable of producing reliable and reproducible results in measuring proximal tooth contact. Therefore, it was considered that this device was appropriate to apply clinically.

• JSTS:Journal of Semiconductor Technology and Science
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• v.17 no.1
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• pp.147-155
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• 2017

A new endurance test-pattern generation on NAND-flash memory is proposed to improve test cost. We mainly focus on the correlation between the data-pattern and the device error-rate during endurance testing. The novelty is the development of testing method using quasi-random pattern based on device architectures in order to increase the test efficiency during time-consuming endurance testing. It has been proven by the experiments using the commercial 32 nm NAND flash-memory. Using the proposed method, the error-rate increases up to 18.6% compared to that of the conventional method which uses pseudo-random pattern. Endurance testing time using the proposed quasi-random pattern is faster than that of using the conventional pseudo-random pattern since it is possible to reach the target error rate quickly using the proposed one. Accordingly, the proposed method provides more low-cost testing solutions compared to the previous pseudo-random testing patterns.

• Genomics & Informatics
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• v.12 no.4
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• pp.151-155
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• 2014

In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.

• Journal of Dental Anesthesia and Pain Medicine
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• v.16 no.4
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• pp.303-307
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• 2016

Background: In dental intravenous sedation, continuous intravenous infusion of a low-dose drug requires an infusion pump such as a syringe pump. To develop a new syringe pump for clinical use, the functions of the pump must meet certain international standards. Various safety and efficacy tests must be performed on the syringe pump, as stipulated by these standards, and an approval must be received from the approving agency based on such test results. Methods: The authors of the present study developed a novel syringe pump and performed efficacy evaluation by testing its infusion speed at 1 and 25 ml/h, and infusion performance testing at 2 and 24 h. Moreover, performance evaluation was conducted by comparing the novel pump to an existing pump with the infusion speed varied from 1 to 5 ml/h. Results: In the efficacy testing on the newly developed syringe pump, infusion with the infusion speed initially set to 1 ml/h resulted in infusion speeds of 1.00 and 0.99 ml/h in the 2- and 24-h assessment, respectively. Changing the infusion speed setting to 25 ml/h resulted in an infusion speed of 25.09 and 23.92 ml/h in the 2- and 24-h assessment, respectively. These results show no significant differences when compared with other commercially available pumps. Conclusions: The efficacy testing of the newly developed syringe pump showed the accuracy to be within tolerance. Based on these findings, we believe that the newly developed syringe pump is suitable for clinical use.

• Journal of Applied Reliability
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• v.17 no.3
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• pp.236-245
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• 2017

Purpose: There is no established inspection system for composite wind blade during the fabrication stage even though the blades are one of the most important part at wind generation system, but phased array ultrasonic testing method has been continuously studied about wind turbine blade with composite. When wind turbine blade with complex shape by phased array probe is inspected, it is necessary to study for system keeping constant pressure using pressure device. Methods: In this paper, we propose constant pressure device for inspecting wind turbine blade by phased array ultrasonic test method. Design of the device controller is based on Hunt-Crossley model. We evaluate reliability of phased array ultrasonic inspection result that applicated constant pressure device. Result: Defect indication is precise and its error is small when constant pressure mechanism based on Hunt-Crossley model was used. Conclusion: When inspection is progressed using constant pressure mechanism, the reliability of composite wind blade inspection can be improved.

• Journal of the Korean Society for Precision Engineering
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• v.32 no.10
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• pp.911-916
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• 2015

In the nano/micro scale, material properties are dependent on the size-scale of a structure. However, conventional micro-scale tensile tests have limitations to obtain reliable values of nano-scale material properties owing to residual stress and elastic slippage in the gripping/aligning process. The indenter-driven nano-scale tensile test provides prominent advantages simple testing device, high-quality nano-scale metallic specimen with negligible residual stress. In this paper, two-types of specimens (a specimen with multi-testing parts and a specimen with a single-testing part) are discussed. Focused ion beam (FIB) is employed to fabricate a nano-scale specimen from a thin nickel film. Using the specimen with a single-testing part, we obtained a nano-scale stress-strain curve of electroplated nickel film.