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10.1177/1932296815580160 http://scihub22266oqcxt.onion/10.1177/1932296815580160 C4525642!4525642 !25872965     free     free     free Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 243.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 243.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 243.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 243.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 243.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 243.2 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 276.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 276.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 276.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 276.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 276.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 276.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 276.79999999999995 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 310.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 310.4 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Warning: imagejpeg(C:\Inetpub\vhosts\kidney.de\httpdocs\phplern\25872965 .jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117       J+Diabetes+Sci+Technol 2015 ; 9 (4 ): 885-94 Nephropedia Template TP {{tp|p=25872965 |t=2015. Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations |pdf=|usr=}}{{25872965 }} gab.com Text Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations JO: J Diabetes Sci Technol http://www.kidney.de/pget.php?&tw=1&pmid=25872965 #FOAvip In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood glucose (SMBG) before the market approval. In 2013, a revised version of this standard was published. Relevant revisions in the analytical performance requirements are the inclusion of the evaluation of influence quantities, for example, hematocrit, and some changes in the testing procedures for measurement precision and system accuracy evaluation, for example, number of test strip lots. Regarding system accuracy evaluation, the most important change is the inclusion of more stringent accuracy criteria. In 2014, the Food and Drug Administration (FDA) in the United States published their own guidance document for the premarket evaluation of SMBG systems with even more stringent system accuracy criteria than stipulated by ISO 15197:2013. The establishment of strict accuracy criteria applicable for the premarket evaluation is a possible approach to further improve the measurement quality of SMBG systems. However, the system accuracy testing procedure is quite complex, and some critical aspects, for example, systematic measurement difference between the reference measurement procedure and a higher-order procedure, may potentially limit the apparent accuracy of a given system. Therefore, the implementation of a harmonized reference measurement procedure for which traceability to standards of higher order is verified through an unbroken, documented chain of calibrations is desirable. In addition, the establishment of regular and standardized post-marketing evaluations of distributed test strip lots should be considered as an approach toward an improved measurement quality of available SMBG systems. Twit Text FOAVip Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations ????J Diabetes Sci Technol http://www.kidney.de/pget.php?&tw=1&pmid=25872965 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=25872965 #FOAvip English Wikipedia <ref>{{Cite pmid|25872965 }}</ref> Analytical Performance Requirements for Systems for Self-Monitoring of Blood Glucose With Focus on System Accuracy: Relevant Differences Among ISO 15197:2003, ISO 15197:2013, and Current FDA Recommendations #MMPMID25872965 Freckmann G ; Schmid C ; Baumstark A ; Rutschmann M ; Haug C ; Heinemann L J Diabetes Sci Technol 2015[Jul]; 9 (4 ): 885-94 PMID25872965 show ga In the European Union (EU), the ISO (International Organization for Standardization) 15197 standard is applicable for the evaluation of systems for self-monitoring of blood glucose (SMBG) before the market approval. In 2013, a revised version of this standard was published. Relevant revisions in the analytical performance requirements are the inclusion of the evaluation of influence quantities, for example, hematocrit, and some changes in the testing procedures for measurement precision and system accuracy evaluation, for example, number of test strip lots. Regarding system accuracy evaluation, the most important change is the inclusion of more stringent accuracy criteria. In 2014, the Food and Drug Administration (FDA) in the United States published their own guidance document for the premarket evaluation of SMBG systems with even more stringent system accuracy criteria than stipulated by ISO 15197:2013. The establishment of strict accuracy criteria applicable for the premarket evaluation is a possible approach to further improve the measurement quality of SMBG systems. However, the system accuracy testing procedure is quite complex, and some critical aspects, for example, systematic measurement difference between the reference measurement procedure and a higher-order procedure, may potentially limit the apparent accuracy of a given system. Therefore, the implementation of a harmonized reference measurement procedure for which traceability to standards of higher order is verified through an unbroken, documented chain of calibrations is desirable. In addition, the establishment of regular and standardized post-marketing evaluations of distributed test strip lots should be considered as an approach toward an improved measurement quality of available SMBG systems. |Blood Glucose Self-Monitoring/*instrumentation/methods/*standards [MESH] |Blood Glucose/*analysis [MESH] |Diabetes Mellitus/*blood [MESH] |Europe [MESH] |Guidelines as Topic [MESH] |Hematocrit [MESH] |Humans [MESH] |Hypoglycemia/diagnosis [MESH] |Reproducibility of Results [MESH] |United States [MESH]Analytical Performance Requirements for Systems for Self-Monitoring of(epmc).pdf DeepDyve Pubget Overpricing