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KMID : 1142220190140010099
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Regulatory Research on Food, Drug & Cosmetic
2019 Volume.14 No. 1 p.99 ~ p.104
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Advanced Technology and Performance Evaluation Method for Safety Improvement of Ophthalmic Laser Equipment
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Kim Dae-Chang
Jeong Jae-Hoon
Kim Sung-Min
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Abstract
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Retinal diseases caused by chronic diseases such as hypertension and diabetes are increasing in number every year. It is a factor in blindness and vision impairment. so, the demand of treatment using ophthalmic laser equipment is increasing as a way to manage and treat it. However, ophthalmic laser equipment should have high safety, and it is difficult for domestic manufacturers to develop their own products due to lack of clear information on technology and evaluation method. To solve these problems, this study investigated and analyzed IEC 60825- 1 to derive biological and physical hazards that could occur in the retina and to investigate advanced technologies that could lower the risk factors. Although the technology must meet the international standard of IEC 60601- 2-22 for use as a medical device, additional performance evaluation methods are proposed because of the lack of evaluation method for ophthalmic laser equipment. As a result, this will allow patients to manage and treat retinal diseases using the ophthalmic laser equipment with improved safety, the development of ophthalmic laser equipment will be activated. Finally, we will have the opportunity to activation the domestic market and enter the global market.
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KEYWORD
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Ophthalmic Laser Equipment, Safety, Advanced Technology, Evaluation Methods
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