ISO 15197:2013 pdf download.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 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 is applicable to manufacturers of such systems and those otherorganizations (e.g. regulatory authorities and conformity assessment bodies) having the responsibility for assessing the performance of these systems.
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
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes ISO 14971, Medical devices — Application of risk management to medical devices
ISO 17511, In vitro diagnostic medical devices — Measurement of quantities in biological samples
Metrological traceability of values assigned to calibrators and control materials
ISO 18 113-1, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
ISO 18113-4, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing
ISO 18113-5, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
ISO 23640, In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
IEC 60068-2-64, Environmental testing — Part 2-64: Tests — Test Fh: Vibration, broadband random and guidance
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 18113-1 and the following apply.
3.1
blood-glucose monitoring system
measuring system consisting of a portable instrument and reagents used for the in vitro monitoring of glucose concentrations in blood
Note 1 to entry: Blood-glucose monitoring systems measure glucose in capillary blood samples, but can express measured values as either the glucose concentration in capillary blood or the equivalent glucose concentration in capillary plasma. Concentrations in this International Standard refer to the type of measured values reported by the system.
3.2
blood-glucose meter
component of a blood-glucose monitoring system that converts the product of a chemical reaction into the glucose concentration of the sample.ISO 15197 pdf download.