Infant·childhood is the time to experience a big change physically and physiologically. Because there would be high possibility to cause a harmful influence in the long term if the exposure to hazards, it is required to manage the medical devices for an infant and a child strictly by preparing the standards to be applied the characteristics of an infant and a child. Among these medical electrical equipment, a Phototherapy unit is one of most important equipment to be used frequently in the hospitals in order to treat infant so that the standard for a Phototherapy unit is required to evaluate the safety and performance of the equipment. To develop the standard of a Phototherapy unit, the following international standards were examined; KS C 60601-2-50 a Phototherapy unit, IEC 60601-2-50(2000): a Phototherapy unit, EN 60601-2-50 (2000): a Phototherapy unit, KFDA guideline for a Phototherapy, the standards of manufacturers. In this study, through survery and inspection of international standards and guideline for a phototherapy unit, survery and inspection of international and domestic manufacturers' test items, proposals standards for the product by technical review, we suggest the standard for a Phototherapy Unit.
목차
초록 I. 서론 II. 본론 1. 신생아황달치료용광선조사기 개요 2. 용어의 정의 3. 신생아황달치료용광선조사기 관련 국내외 규격 현황 4. 신생아황달치료용광선조사기 국내외 규격 비교 III. 결론 감사의 말 참고문헌 Abstract
한국에프디시규제과학회(구 한국에프디시법제학회) [The Korean Society of Food, Drug and Cosmetic Regulatory Sciences]
설립연도
2006
분야
의약학>약학
소개
본회는 의약품, 의약외품, 의료기기, 화장품 및 건강기능식품 등과 관련된 국내·외의 각종 법령과 규정 등에 대한 연구와 발표 등을 통하여 합리적이고 투명한 법령과 규정의 제·개정 및 정책개발에 기여함으로써 관련 산업의 발전과 국민의 건강증진에 기여하며 회원 상호 간의 친목을 도모함을 목적으로 한다.
간행물
간행물명
KFDC규제과학회지(구 FDC법제연구) [Regulatory Research on Food, Drug and Cosmetic]