BS EN ISO 15197:2015

What is ISO 15197 - Blood glucose monitoring systems about?

ISO 15197 is an international standard on in-vitro diagnostic tests that discusses blood glucose monitoring systems for self-testing in managing diabetes mellitus for in-vitro diagnostic test systems. ISO 15197 outlines 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 laypersons for the management of diabetes mellitus.

ISO 15197 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.

Note: ISO 15197 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

Who is ISO 15197 - Blood glucose monitoring systems for?

ISO 15197 on blood glucose monitoring systems for self-testing in managing diabetes mellitus for in-vitro diagnostic test systems is useful for:

• Medical laboratories
• Manufacturers of diabetes detection and management systems
• Healthcare professionals
• Research centres
• Regulatory authorities

Why should you use ISO 15197 - Blood glucose monitoring systems?

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 result in acute and chronic health complications

ISO 15197 guideline assists you with design and development on metrological traceability, safety and risk management, ergonomics and human factors, and user verification requirements for blood glucose monitoring systems for self-testing in managing diabetes mellitus for in-vitro diagnostic test systems.

Although, ISO 15197 does not apply to glucose monitoring systems that provide measured values on an ordinal scale or medical devices that measure blood-glucose continuously for self-monitoring, it may be useful as a guide for developing procedures to evaluate the performance of such systems.

ISO 15197 will support you with proper guidance on blood glucose monitoring systems for self-testing in managing diabetes mellitus. Using ISO 15197 you will be able to evaluate in-vitro blood glucose monitoring systems for laypersons and develop better products.