In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (Adopted ISO 15197:2013, second edition, 2013-05-15)
CSA Preface This is the second edition of CAN/CSA-ISO 15197, In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus , which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 15197 (second edition, 2013-05-15). It supersedes the previous edition published in 2005 as CAN/CSA-ISO 15197 (adopted ISO 15197:2003). This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group Scope This International Standard 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. This International Standard 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. This International Standard does not
| SDO | CSA: Canadian Standards Association |
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| Publication Date | Jan. 1, 2015 |
| Language | en - English |
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