원문정보
초록
영어
The market size of Intense Pulsed Light (IPL) and the number of its approvals by Ministry of Food and Drug Safety (MFDS) has increased along with increasing needs in skin treatment and aesthetic and antiageing field. Since there are no detailed and optimal domestic and international standards for IPL, it is need to develop the safety and performance guideline for IPL which is directly used to the skin. To develop the guideline for IPL, technical information was collected and applicable internal standards and related foreign standards were surveyed and analyzed. And then essential test items in the guideline were derived to evaluate the safety and performance of IPL; output accuracy and stability, pulse profile (pulse duration, pulse delay), beam size, wavelength, uniformity of output beam and cooling test. As a result, this guideline could help civil petitioners in progress of an approval and review, improvement public health by securing medical devices with consistent quality, and strengthen the competitiveness of the domestic medical device industry.
목차
I. Introduction
II. Research Subject and Method
1. Research subject
2. Study of domestic and foreign standards and specifications
3. Analysis of technical documents of IPLs approved by MFDS
4. Development of a guideline (draft) and operation of a consultative body
III. Result and Discussion
1. Result of studying domestic and international standards
2. Analytical result of technical documents of the approved IPLs
3. Test items for safety and performance evaluation
IV. Conclusion
Acknowledgements
References