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http://dx.doi.org/10.17661/jkiiect.2022.15.6.477

Animal Skin Irritation and Skin Sensitization Tests of High Intensity Focused Ultrasound System Cartridges  

Jun-tae, Kim (Corporate R&D Center ECLEO., Ltd)
Ju-hee, Kim (Corporate R&D Center ECLEO., Ltd)
Kyu-tai, Joo (Corporate R&D Center ECLEO., Ltd)
Kyung-ah, Kim (College of Medicine, Chungbuk National University)
Ahnryul, Choi (Deoartment of Bio-medical Engineering, Catholic Kwandong University)
Jae-hyun, Jo (Deoartment of Bio-medical Engineering, Catholic Kwandong University)
Jin-houng, Jeong (Deoartment of Biomedical IT, Catholic Kwandong University)
Publication Information
The Journal of Korea Institute of Information, Electronics, and Communication Technology / v.15, no.6, 2022 , pp. 477-484 More about this Journal
Abstract
In this study, the cartridge part of the focused ultrasound stimulation system was used as a sample to conduct a skin irritation test and a skin sensitization test through animal experiments among the tests related to GLP (Good Laboratory Practice), a medical device safety evaluation standard. The test was conducted after IACUC approval using 6 female New Zeland White Rabbits. The polar and non-polar stimulation indices were all '0.0'. In addition, in the case of skin sensitization evaluation, 30 guinea pigs approved by IACUC were divided into control and experimental groups, and all induction and induction steps were applied using the eluate itself without separate dilution of the test sample and blank test solution. As a result of the experiment, the skin reaction grade of the control animal was 0 grade, and there was no animal showing more than 1 grade in the skin reaction of the test animal. As a result of both tests, no abnormal skin symptoms were observed, and when applied to the human body to treat patients, the test materials used in the tests will investigate the stability of whether any diseases that cause skin abnormal symptoms will occur.
Keywords
HIFU(High Intensity Focused Ultrasound); Skin irritation test; Skin sensitization test; GLP(Good Labotory Practice); IACUC(Institutional Animal Care and Use Committee); Non-clinical trial;
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  • Reference
1 Jin-ah, Hwang, Dong-Hwan, Kim, Chin-chul, Shin, Eun-ji, Lee, Sam-song, Choi, Jong-sik, Gam, "A Study on Establishment of Good Laboratory Practice Guidebook", FDC Legislative Research, 15(1), p. 9 ~ 18, 2020
2 Ministry of Food and Drug Safety Notice No. 2018-93 (2018.11.21.) Non-clinical test management standard
3 OECD Principles of Good Laboratory Practice(as revised in 1997), ENV/MC/CHEM(98)17
4 ISO 10993-23 :2021, Biological Evaluation of Medical Devices - Part 23 : Tests for irritation, 7.2 Animal irritation test by skin exposure
5 ISO 10993-12 : 2021, Biological Evaluation of Medical Devices - Part 12 : Sample Preparation and reference materials
6 ISO 10993-2 : 2006, Biological Evaluation of Medical Devices - Part 2 : Animal welfare requirements.
7 Ministry of Food and Drug Safety Notice No. 2018-93 Emergency Test Management Standard
8 OECD Principles of Good Laboratory Practice(as revised in 1997), ENV/MC/ CHEM(98)17
9 Anthony Grisey, Marc Heidmann, Veronique Letort, Pauline Lafitte, Sylvain yon, "Influence of Skin and Subcutaneous Tissue on High-Intensity Focused Ultrasound Beam: Experimental Quantification and Numerical Modeling", Journal of Ultrasound Med Biol, 42(10), 2016, PP.2457-65   DOI
10 Jan Kottner, Janet Cuddigan, Keryln Carville, Katrin Balzer, Dan Berlowitz, Susan Law, Mary Litchford, Pamela Mitchell, Zena Moore, Joyce Pittman, Dominique Saguado-Roussel, Chang YEE YEE, Emilty Haesler, "Prevention and treatment of pressure ulcers/injuries: The protocol for the second update of the international Clinical Practice Guideline 2019", Journal of Tissue Viability, 28(2), 2019, PP. 51-58   DOI
11 Frederick E Reno, C Nichlas Edwards, Morten Bendix Jensen, Magdolna Torok-Batho, David J Esdaile, Claude Piche, Myriam Triest, Dolores Carballo, "Needle-free nasal delivery of glucagon for treatment of diabetes-related severe hypoglycemia: toxicology of polypropylene resin used in delivery device", Journal of Cutan Ocul Toxicol, 35(3), 2016, PP.242-7   DOI
12 Draize JH, Woodard G, Calvery HO, "Methods for the Study of Irritation and Toxicity of Substances Applied Topically to the Skin and Mucous Membranes", Journal of. Pharmacol. Exp. Ther 82, 1944, PP. 377.