ISO 15197-2013 pdf free.In vitro diagnostic test systems —Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197 specifies requirements for in vitro glucose monitoring systems that measureglucose concentrations in capillary blood samples, for specific design verification procedures and forthe validation of performance by the intended users.These systems are intended for self-measurementby lay persons for management of diabetes mellitus. This International Standard is applicableto manufacturers of such systems and those other organizations(e.g.regulatory authorities and conformity assessment bodies) having the responsibility for assessingthe performance of these systems. This International Standard does not: provide a comprehensive evaluation of all possible factors that could affect the performance ofthese systems, pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus,address the medical aspects of diabetes mellitus management, apply to measurement procedures with measured values on an ordinal scale (e.g. visual,semiquantitative measurement procedures), or to continuous glucose monitoring systems, apply to glucose meters intended for use in medical applications other than self-testing for themanagement of diabetes mellitus 2Normative references The following referenced documents are indispensable for the application of this document.For datedreferences, only the edition cited applies.For undated references, the latest edition of the referenceddocument (including any amendments) applies. ISO…