Abstract ▼

The goal of this study is to harmonize the current “Common Standards on Electromagnetic Safety of Medical Devices” with international standards. The latest international standard for medical device electromagnetic reflects the convergence of medical devices with information and communication technol

The goal of this study is to harmonize the current “Common Standards on Electromagnetic Safety of Medical Devices” with international standards. The latest international standard for medical device electromagnetic reflects the convergence of medical devices with information and communication technology, reclassification of medical devices according to the use environment, and risk management (ISO 14971) procedures to ensure basic safety and essential performance of medical devices. it is not harmonized with domestic standards, causing a weakening of industrial competitiveness due to the delay of technological development of domestic medical device manufacturers. Consumer safety is a problem caused by the commercial distribution of products that do not have the latest safety and performance standards.

To this end, this study has updated the current common standards on the electromagnetic safety of medical devices. The contents were compared and analyzed in the latest version of theinternational standards(‘CISPR 11,Ed.6.1(2016)’ and ‘IEC 60601-1-2 Ed.4.0(2014)’) harmonized with domestic standards.(‘CISPR 11,Ed.5.1(2010)’ and ‘IEC 60601-1-2 Ed.3.0(2007)’)

Based on the analysis, the results of the analysis and the reasons for the revision were presented. In order to establish a changed test procedure, a Korean test report was prepared. Itwas performed and verified by the actual sample test based on a written test report.

In addition, when the revised standard is applied, the commission is expected to increase as the number of test execution procedures increases. Expected test commission were surveyed by 8EMC test laboratories currently designated by the KFDA. And the average increase of fee byeach test institute was presented.

Finally, When applying the revised standard, we conducted a survey on the 'medical device licensed and licensed companies' who have the highest interest and whether they have any difficulties due to the introduction of the 4 edition.

(출처 : SUMMARY 8p)

목차 Contents

• 표지 ... 1
• 최종보고서 ... 2
• 제 출 문 ... 3
• 목차 ... 4
• Ⅰ. 총괄연구개발과제 요약문 ... 6
• 국문 요약문 ... 6
• Summary ... 8
• Ⅱ. 총괄연구개발과제 연구결과 ... 10
• 제1장 총괄연구개발과제의 목적 및 필요성 ... 10
• 제2장 총괄연구개발과제의 내용 및 방법 ... 21
• 제3장 총괄연구개발과제의 최종결과 및 고찰 ... 24
• 제4장 총괄연구개발과제의 연구성과 ... 47
• 제5장 총괄주요연구 변경사항 ... 49
• 제6장 총괄참고문헌 ... 50
• 제7장 총괄첨부서류 ... 52
• 끝페이지 ... 53