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1.
Technol Health Care ; 26(S1): 291-306, 2018.
Article in English | MEDLINE | ID: mdl-29710757

ABSTRACT

This study was conducted according to the method presented in the Republic of Korea Pharmacopoeia 11th Revision, aseptic test method to evaluate the suitability of sterilization for a sterile needle (4 Pin Multi-needle). In this study, four tests were conducted: sterility test, cytotoxicity test, acute toxicity test, skin sensitization test. First, in the aseptic test, the microorganism was not proliferated in the aseptic test of the medium. As a result of the performance test of the medium, it was confirmed that the microorganism developed within 3 days and the fungus was evident within 5 days. Based on this, it was confirmed that the medium was suitable, and as a result of the aseptic test, the development of microorganisms was not observed during the total culture period. Based on these results, tests were conducted which were confirmed to be suitable for aseptic testing because the development of bacteria on the provided samples was not recognized. For cytotoxicity tests ISO10993-5; 2009 (Biological Evaluation of Medical Devices, Part 5: Test for in vitro Cytotoxicity). As a result, the MEM eluate of the test substance caused very slight cytotoxicity to the fibroblasts of the mouse and was judged to be Grade 1 (Slightly cytotoxic) according to the judgment standard of ISO 10993-5. On the other hand, solvent control, negative control and positive control showed the expected results on the test. Acute Toxicity Test Results: It was judged that there was no systemic toxicity change when ICR mice were treated with 50 mL/kg B.W. of the eluate of sterile injectable needle for 72 hours. Skin sensitization test result: The Hartley guinea pig was evaluated as a substance which is evaluated as a substance which does not induce any skin reaction when skin sensitization is applied to the dissected material of the sterile injectable needle and is weak in skin sensitivity. Based on the above tests, we will study the stability and efficacy of more reliable medical devices based on the verification and performance of medical devices.


Subject(s)
Mesotherapy/methods , Needles/microbiology , Sterilization/methods , Animals , Dermatitis, Allergic Contact/microbiology , Fibroblasts/microbiology , Guinea Pigs , Mice , Reproducibility of Results , Republic of Korea , Skin Tests , Sterilization/standards , Toxicity Tests
2.
Technol Health Care ; 24 Suppl 2: S569-75, 2016 Apr 29.
Article in English | MEDLINE | ID: mdl-27163319

ABSTRACT

An abdominal aortic aneurysm doesn't result in specific symptoms, and so providing a successful diagnosis can be challenging. Patients may require surgery for successful treatment, with the risk of aortic rupture being dependent on diameter. In this study, a CT screen of a patient with an aneurysm of the abdominal aorta was processed. In order to provide a more accurate and comfortable diagnosis, and to more easily determine the diameter of the abdominal aortic aneurysm, the Sobel and Top-hat methods were employed. Using a filtered screen overlap for the CT scan, the aortic diameter of a patient could be compared with the diameter of a healthy individual, thus allowing an immediate and accurate comparison. It was found that with a diameter of more than 40 mm the risk of rupture is higher.


Subject(s)
Aortic Aneurysm, Abdominal/diagnostic imaging , Aortic Aneurysm, Abdominal/pathology , Aortic Rupture , Humans , Risk Assessment , Tomography, X-Ray Computed/methods
3.
Biomed Mater Eng ; 26 Suppl 1: S1193-9, 2015.
Article in English | MEDLINE | ID: mdl-26405878

ABSTRACT

In this study, the radiation generated in the diagnosis of scoliosis, to solve the problems by using an infrared camera and an optical marker system that can diagnose scoliosis developed. System developed by the infrared camera attached to the optical spinal curvature is recognized as a marker to shoot the angle between the two optical markers are measured. Measurement of angle, we used the Cobb's Angle method used in the diagnosis of spinal scoliosis. We developed a software to be able to output to the screen using an infrared camera to diagnose spinal scoliosis. Software is composed of camera output unit was manufactured in Labview, angle measurement unit, in Cobb's Angle measurement unit. In the future, kyphosis, Hallux Valgus, such as the diagnosis of orthopedic disorders that require the use of a diagnostic system is expected case.


Subject(s)
Anatomic Landmarks/pathology , Fiducial Markers , Image Interpretation, Computer-Assisted/methods , Photography/instrumentation , Photography/methods , Scoliosis/pathology , Adolescent , Equipment Design , Equipment Failure Analysis , Female , Humans , Imaging, Three-Dimensional/methods , Infrared Rays , Male , Reproducibility of Results , Sensitivity and Specificity
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