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.
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.