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KMID : 1142220110060010053
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Regulatory Research on Food, Drug & Cosmetic
2011 Volume.6 No. 1 p.53 ~ p.58
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The Study on Performance Evaluation for Diagnostic Spirometer
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Cho Eun-Jeong
Cha Ji-Hun
Kwon Tae-Hee
Kim San
Hur Chan-Hoi
Oh Hyeon-Joo
Kim Dong-Sub
Park Ki-Jung
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Abstract
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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.
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KEYWORD
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Diagnostic spirometer, Respiratory ailments (Pulmonary disease), Performance test
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