ISO 15197 guideline | 合法醫療器材資訊網
由NBreitenbeck著作·2017·被引用1次—TheInternationalOrganizationforStandardization(ISO)standard15197:2013andtheEuropeanharmonizedversionENISO15197:2015areusedtoestablish ...,由GFreckmann著作·2015·被引用46次—AccordingtoISO15197,evaluationofSMBGsystemaccuracyshouldbeperformedwithatleast100capillarybloodsamplesfromdifferentsubjects ...,ENISO15197:2015-ISO15197:2013specifiesrequirementsforinvitroglucosemonitoringsystemsthatmeasureglucoseconcentrationsincapillaryblood ...,由NJendrike著作·2017·被引...
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Accuracy Assessment of a Blood Glucose Monitoring System ... | 合法醫療器材資訊網
由 N Breitenbeck 著作 · 2017 · 被引用 1 次 — The International Organization for Standardization (ISO) standard 15197:2013 and the European harmonized version EN ISO 15197:2015 are used to establish ... Read More
Analytical Performance Requirements for Systems for Self ... | 合法醫療器材資訊網
由 G Freckmann 著作 · 2015 · 被引用 46 次 — According to ISO 15197, evaluation of SMBG system accuracy should be performed with at least 100 capillary blood samples from different subjects ... Read More
EN ISO 15197:2015 | 合法醫療器材資訊網
EN ISO 15197:2015 - ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood ... Read More
ISO 15197 | 合法醫療器材資訊網
由 N Jendrike 著作 · 2017 · 被引用 12 次 — Requirements for blood glucose monitoring systems (BGMS) for self-testing are regulated, for example, in the international standard ISO 15197:2013 ... Read More
ISO 15197 | 合法醫療器材資訊網
This International Standard is intended for blood-glucose monitoring systems used by laypersons. The primary objectives are to establish requirements that ... Read More
ISO 15197 | 合法醫療器材資訊網
ISO 15197 | 合法醫療器材資訊網
This International Standard is intended for blood-glucose monitoring systems used by lay persons. The primary objectives are to establish requirements that ... Read More
ISO Standards for Blood Glucose Meters | 合法醫療器材資訊網
The ISO guidelines for blood glucose meters are a detailed set of ... need to be met are the set of standards that were published in 2003 (ISO: 15197:2003). Read More
Relevant Differences Among ISO 15197 | 合法醫療器材資訊網
Regarding minimum accuracy criteria, ISO 15197:2013 stipulates that at least 95% of measurement results (Freckmann, 2015) . Therefore, the current production ... Read More
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