This is the first edition of CAN/CSA-ISO 15197, In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15197 (first edition, 2003-05-01). This Standard replaces CSA Z316.4-94, Performance Specifications for Portable Whole Blood Glucose Monitor Systems for Use in Diabetes Management.
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 validation of performance by the intended users. These systems are intended for self-testing by laypersons for management of diabetes mellitus.
This International Standard is applicable to manufacturers of such systems and those other organizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.
This International Standard does not
- provide a comprehensive evaluation of all possible factors that could affect the performance of these systems,
- pertain to glucose concentration measurement for the purpose of diagnosing diabetes mellitus,
- address the medical aspects of diabetes mellitus management, or
- apply to measurement procedures with results on an ordinal scale (e.g. visual, semiquantitative test methods).