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<p>ISO 17593:2007 specifies requirements for <i>in vitro</i> measuring systems for self-monitoring of vitamin-K antagonist therapy, including performance, quality assurance and user training and procedures for the verification and validation of performance by the intended users under actual and simulated conditions of use. </p>
<p>ISO 17593:2007 pertains solely to prothrombin time measuring systems used by individuals for monitoring their own vitamin-K antagonist therapy, and which report results as international normalized ratios (INR). </p>
<p>ISO 17593:2007 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.</p>
<p>ISO 17593:2007 does not</p>
<ul>
<li>pertain to <i>in vitro</i> measuring systems for coagulation quantities assessing vitamin-K antagonist therapy used by physicians or healthcare providers, </li>
<li>provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, or</li>
<li>address the medical aspects of oral anticoagulation therapy. </li>
</ul>
Reģistrācijas numurs (WIID)
36872
Darbības sfēra
<p>ISO 17593:2007 specifies requirements for <i>in vitro</i> measuring systems for self-monitoring of vitamin-K antagonist therapy, including performance, quality assurance and user training and procedures for the verification and validation of performance by the intended users under actual and simulated conditions of use. </p>
<p>ISO 17593:2007 pertains solely to prothrombin time measuring systems used by individuals for monitoring their own vitamin-K antagonist therapy, and which report results as international normalized ratios (INR). </p>
<p>ISO 17593:2007 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.</p>
<p>ISO 17593:2007 does not</p>
<ul>
<li>pertain to <i>in vitro</i> measuring systems for coagulation quantities assessing vitamin-K antagonist therapy used by physicians or healthcare providers, </li>
<li>provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, or</li>
<li>address the medical aspects of oral anticoagulation therapy. </li>
</ul>
