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  • ISO 15197:2013 - In vitro diagnostic test systems — Requirements for . . .
    ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users These systems are intended for self-measurement by lay persons for management of diabetes mellitus
  • ISO 15197: 2013 Evaluation of a Blood Glucose Monitoring System’s . . .
    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
  • In vitro diagnostic test systems — Requirements for blood-glucose . . .
    ISO 15197:2013(E) Introduction Blood-glucose monitoring systems are in vitro diagnostic medical devices used predominantly by individuals affected by diabetes mellitus Diabetes mellitus is caused by a deficiency in insulin secretion or by insulin resistance leading to abnormally high concentrations of glucose in the blood, which may
  • ISO 15197:2013 — Blood-Glucose Monitoring Systems - ANSI Blog
    ISO 15197:2013 is applicable to manufacturers of such systems and those other organizations (e g , regulatory authorities and conformity assessment bodies) that have the responsibility for assessing the performance of in vitro glucose monitoring systems What Are the Types of Diabetes? Diabetes mellitus has several categories, including the
  • ISO15197 | In vitro diagnostic test systems — Requirements for blood . . .
    This International Standard specifies procedures for the determination of performance criteria for quantitative in vitro blood glucose monitoring systems for management of diabetes mellitus
  • ISO 15197:2013 In Vitro Diagnostic Test Systems
    ISO 15197:2013 specifies the requirements for in vitro diagnostic (IVD) test systems intended for self-monitoring of blood glucose concentrations by individuals with diabetes mellitus
  • ISO 15197 - In vitro diagnostic test systems - Engineering360
    In Vitro Diagnostic Test Systems - Requirements for Blood-Glucose Monitoring Systems for Self-Testing in Managing Diabetes Mellitus This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the
  • User Performance Evaluation of Four Blood Glucose Monitoring Systems . . .
    The international standard ISO 15197:2013 requires a user performance evaluation to assess if intended users are able to obtain accurate blood glucose measurement results with a self-monitoring of blood glucose (SMBG) system
  • ISO-15197 | In vitro diagnostic test systems - Document Center, Inc.
    ISO 15197:2013 specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples, for specific design verification procedures and for the validation of performance by the intended users These systems are intended for self-measurement by lay persons for management of diabetes mellitus
  • ISO 15197:2013 Accuracy Evaluation of Two CE-Marked Systems for Self . . .
    Proof of conformity with the international standard ISO 15197, which describes accuracy criteria for SMBG systems, is often performed by manufacturers to obtain a CE mark for their system A new version of this standard with tighter accuracy criteria was published in 2013 1 and will replace ISO 15197:2003 2 after a transition period of 3 years





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