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<p>This document specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist oral anticoagulation therapy, including performance, quality assurance and user training and procedures for the validation of performance by the intended users under actual and simulated conditions of use.</p>
<p>This document applies solely to prothrombin time measuring systems used by lay persons for monitoring their own vitamin-K antagonist oral anticoagulation therapy, and which report results as international normalized ratios (INR).</p>
<p>This document 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>This document is not applicable to:</p>
<p>— in vitro measuring systems for coagulation quantities assessing vitamin-K antagonist oral anticoagulation therapy used by physicians or healthcare providers;</p>
<p>— non-vitamin-K antagonist oral anticoagulation therapy (e.g. dabigatran);</p>
<p>— a comprehensive evaluation of all possible factors that can affect the performance of these systems;</p>
<p>— the medical aspects of oral-anticoagulation therapy.</p>
Reģistrācijas numurs (WIID)
79378
Darbības sfēra
<p>This document specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist oral anticoagulation therapy, including performance, quality assurance and user training and procedures for the validation of performance by the intended users under actual and simulated conditions of use.</p>
<p>This document applies solely to prothrombin time measuring systems used by lay persons for monitoring their own vitamin-K antagonist oral anticoagulation therapy, and which report results as international normalized ratios (INR).</p>
<p>This document 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>This document is not applicable to:</p>
<p>— in vitro measuring systems for coagulation quantities assessing vitamin-K antagonist oral anticoagulation therapy used by physicians or healthcare providers;</p>
<p>— non-vitamin-K antagonist oral anticoagulation therapy (e.g. dabigatran);</p>
<p>— a comprehensive evaluation of all possible factors that can affect the performance of these systems;</p>
<p>— the medical aspects of oral-anticoagulation therapy.</p>
