CAN/CSA-ISO 15197:15 (R2020) ✓ Most Recent

Preface:

This is the second 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 (second edition, 2013-05-15). It supersedes the previous edition published in 2005 as CAN/CSA-ISO 15197 (adopted ISO 15197:2003).

For brevity, this Standard will be referred to as "CAN/CSA-ISO 15197" throughout.

Scope:

This International Standard 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.

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,
• 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 the management of diabetes mellitus.

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