标准编号：ISO 17593:2007
中文名称：临床试验室试验和体外医疗设备 口服抗凝药疗法自我测试用体外监控系统要求
英文名称：Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
发布日期：2007-04
标准范围
This International Standard specifies requirements for in vitro measuring systems for self-monitoring ofvitamin-K antagonist therapy, including performance, quality assurance and user training and procedures forthe verification and validation of performance by the intended users under actual and simulated conditions ofuse.This International Standard pertains solely to prothrombin time measuring systems used by individuals formonitoring their own vitamin-K antagonist therapy, and which report results as international normalized ratios(INR).This International Standard is applicable to manufacturers of such systems and those other organizations (e.g.,regulatory authorities and conformity assessment bodies) having the responsibility for assessing theperformance of these systems.This International Standard does not-- pertain to in vitro measuring systems for coagulation quantities assessing vitamin-K antagonist therapyused by physicians or healthcare providers,-- provide a comprehensive evaluation of all possible factors that could affect the performance of thesesystems, or-- address the medical aspects of oral-anticoagulation therapy.
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