ISO 15197:2013 (R2018)
Active , Reaffirmed Standard
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ISO 15197:2013 (R2018)

In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Summary

ISO 15197:2013 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 15197:2013 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.

Notes

90.60 : Clôture de l'examen

Technical characteristics

Publisher International Organization for Standardization (ISO)
Publication Date 05/14/2013
Confirmation Date 10/24/2018
Edition 2
Page Count 46
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Weight (in grams) ---
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