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ISO 15197:2013

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

standard by International Organization for Standardization , 05/15/2013

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Full Description

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.
 

Product Details

Edition:
2nd
Published:
05/15/2013
Number of Pages:
54
File Size:
1 file , 1.3 MB
Same As:
DIN EN ISO 15197, DIN EN ISO 15197, DIN EN ISO 15197, BS EN ISO 15197:2013, BS EN ISO 15197:2015
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This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 15197:2013

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

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  2. ISO 15197:2003


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

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