本文件规定了维生素K拮抗剂口服抗凝治疗自我监测体外测量系统的要求，包括性能、质量保证和用户培训，以及预期用户在实际和模拟使用条件下验证性能的程序。 本文件仅适用于非专业人士用于监测自身维生素K拮抗剂口服抗凝治疗的凝血酶原时间测量系统，并以国际标准化比率（INR）报告结果。 本文件适用于此类系统的制造商以及负责评估这些系统性能的其他组织（如监管机构和合格评定机构）。 本文件不适用于: -？用于评估医生或医疗保健提供者使用的维生素K拮抗剂口服抗凝治疗的凝血量的体外测量系统； -？非维生素K拮抗剂口服抗凝治疗（如达比加群）； -？对所有可能影响这些系统性能的因素进行综合评估； -？口服抗凝治疗的医学方面。

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.