earticle

영어

The purpose of this study is to develop the guideline to evaluate the performance of diagnostic spirometer. Current development and commercialization status of each category of the diagnostic spirometer is surveyed and summarized as technical information materials. In this research, we investigated the domestic and foreign standards and research trends about the diagnostic spirometer through the relative standards and technical documents. Regarding the performance assessment, the performance test items, protocols and standard values were mostly adopted into regulatory standards based on literature survey such as ATS/ERS 2005 Standardization of Spirometry, ISO 26782 : Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans, and KS C 1222 Clinical electronic spirometer. Performance test items were selected to evaluate the performance of diagnostic spirometer. It is expected that proposed guideline for the diagnostic spirometer will improve the quality of spirometer and increase the international competitive power of domestic medical devices through the internationally harmonized standards.

한국어

생활환경이 변화하고 대기가 오염되어 호흡기 질환 환자가 늘어남에 따라 호흡기 건강 선별 검사에 사용하는 진단폐활량계의 사용도 급증하고 있다. 이러한 추세로 인하여 질환을 정확히 판단할 수 있도록 하는 진단폐활량계의 안전성과 성능이 무엇보다 중요하게 대두되고 있다. 따라서 본 연구에서는 국제규격 및 지침 등을 조사하고 분석하여 시험항목 및 시험방법을 통하여 진단폐활량계의 안전성과 성능을 평가할 수 있는 항목 및 기준을 제시하고자 한다.