ISO 15197 | 合法醫療器材資訊網
由NJendrike著作·2017·被引用10次—Requirementsforbloodglucosemonitoringsystems(BGMS)forself-testingareregulated,forexample,intheinternationalstandardISO15197:2013 ...
Requirements for blood glucose monitoring systems (BGMS) for self-testing are regulated, for example, in the international standard ISO 15197:20131 (harmonized in the European Union as EN ISO 15197:20152). Regarding measuring accuracy of a BGMS, ISO 15197:2013 specifies the following criteria: (1) compared to a traceable laboratory method at least 95% of BGMS results have to be within ±15 mg/dl at glucose concentrations <100 mg/dl and within ±15% at ≥100 mg/dl; (2) in a consensus error grid analysis at least 99% of results have to be within zones A and B.
This study was an ISO 15197:2013 accuracy evaluation at the Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (accredited by the Deutsche Akkreditierungsstelle GmbH (DAkkS) as testing laboratory according to DIN EN ISO/IEC 17025:2005 and 98/79/EC in terms of test procedure...
ISO 15197 | 合法醫療器材資訊網
ISO 15197:2003 | 合法醫療器材資訊網
ISO 15197:2013 | 合法醫療器材資訊網
ISO 15197 | 合法醫療器材資訊網
如何定義血糖機是否準確? | 合法醫療器材資訊網
家用血糖監測系統技術基準 | 合法醫療器材資訊網
由最新的國際標準規格看血糖機精準的必要性與影響檢測準確的 ... | 合法醫療器材資訊網
血糖機的精準度需取得國際ISO 15197認證規範 | 合法醫療器材資訊網
【血中葡萄糖測定儀 3000 型】許可證字號:衛署醫器輸字第019052號
器材品名:血中葡萄糖測定儀3000型許可證字號:衛署醫器輸字第019052號註銷狀態:已註銷註銷日期:2017/01/09註銷理由:許可證已...
【維維樂血糖監測系統】許可證字號:衛部醫器製字第004719號
器材品名:維維樂血糖監測系統許可證字號:衛部醫器製字第004719號註銷狀態:註銷日期:註銷理由:有效日期:2024/10/13發證日期:2...