生体医工学
Online ISSN : 1881-4379
Print ISSN : 1347-443X
ISSN-L : 1347-443X
資料
カフレス血圧計の国際標準化動向と医療機器承認について―戦略的国際標準化推進委員会報告
田村 俊世山口 潤
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ジャーナル フリー

2021 年 59 巻 2-3 号 p. 76-79

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This paper presents the final report of the Committee for Non-Invasive Cardiovascular Monitors Standardization (2018-2020). This committee organized meetings to draft standards for international organizations. At the meetings, cardiovascular physicians, policymakers, and professionals working in digital medicine and healthcare gave advice. We discussed the aims, scope, and clinical evaluations of cuffless blood pressure monitors, summarizing the basic concepts and generating a new proposal. The factors considered included the intended use, static and dynamic accuracy, and long-term stability and validation of cuffless blood pressure monitors. The standards of the International Standards Organization (ISO) and Institute of Electric and Electronic Engineers (IEEE) were followed, and current Pharmaceuticals and Medical Devices Agency (PMDA) and Food and Drug Administration (FDA) recommendations for cuffless blood pressure monitors were reviewed. We discussed existing standards and proposed new ones for cuffless blood pressure monitors. Our proposal will compliment ISO standards for cuffless blood pressure monitors.

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