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 13485,Medical devices —Quality management systems —Requirements for regulatory purposesISO 14971, Medical devices —Application of risk management to medical devices
ISO 17511, In vitro diagnostic medical devices — Measurement of quantities in biological samples 一Metrological traceability of values assigned to calibrators and control materials
ISO 18113-1, In vitro diagnostic medical devices —Information supplied by the manufacturer (labelling)一Part 1: Terms, definitions and general requirements
ISo 18113-4, In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling)一Part 4: In vitro diagnostic reagents for self-testing
ISO18113-5,In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling)一Part 5: In vitro diagnostic instruments for self-testing
ISO 23640, In vitro diagnostic medical devices —Evaluation of stability of in vitro diagnostic reagentsIEC 60068-2-64,Environmental testing — Part 2-64:Tests —Test Fh: Vibration, broadband random andguidance
3 Terms and definitions
For the purposes of this document,the terms and definitions given in ISO18113-1and the following apply.
3.1blood-glucose monitoring system
measuring system consisting of a portable instrument and reagents used for the in vitro monitoring ofglucose concentrations in blood
Note 1 to entry: Blood-glucose monitoring systems measure glucose in capillary blood samples, but can expressmeasured values as either the glucose concentration in capillary blood or the equivalent glucose concentrationin capillary plasma.Concentrations in this International Standard refer to the type of measured values reportedby the system.
3.2blood-glucose meter
component of a blood-glucose monitoring system that converts the product of a chemical reaction intothe glucose concentration of the sample
3.3capillary blood-sample
blood sample collected by skin puncture
Note 1 to entry: A finger punctured by a lancet is commonly called a “fingerstick”.
3.4commutability of a reference material
property of a reference material, demonstrated by the closeness of agreement between the relation amongthemeasurement results forastated quantityin this material, obtainedaccordingto twogiven measurementprocedures, and the relation obtained among the measurement results for other specified materials
Note 1 to entry:The reference material in question is usually a calibrator and the other specified materials areusually routine samples.
Note 2to entry:The measurement proceduresreferredtoin thedefinition aretheonepreceding and theone followingthe reference material (calibrator)in question in a calibration hierarchy.See IS0 17511 for further information.Note 3 to entry:The stability of commutable reference materials is monitored regularly.
[ISO/1EC Guide 99:2007, definition 5.15]
Note 4 to entry: Although blood would be the ideal matrix for reference materials for blood-glucose monitoringdevices, such materials are not available at this time.ISO 15197 pdf download.
Tags: n vitro diagnostic test systems
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