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Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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).
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.
This document is not applicable to:
— in vitro measuring systems for coagulation quantities assessing vitamin-K antagonist oral anticoagulation therapy used by physicians or healthcare providers;
— non-vitamin-K antagonist oral anticoagulation therapy (e.g. dabigatran);
— a comprehensive evaluation of all possible factors that can affect the performance of these systems;
— the medical aspects of oral-anticoagulation therapy.
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