ISO 17593:2007 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

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

ISO 17593:2007规定了维生素K拮抗剂治疗自我监测的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和确认性能的程序。ISO 17593:2007仅涉及个人用于监测其自身维生素K拮抗剂治疗的凝血酶原时间测量系统，其报告结果为国际标准化比值（INR）。ISO 17593:2007适用于此类系统的制造商和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）。ISO 17593:2007没有涉及用于评估维生素的凝血量的体外测量系统-医生或医疗保健提供者使用的K拮抗剂疗法，对可能影响这些系统性能的所有可能因素进行全面评估，或解决口服抗凝治疗的医学方面。

ISO 17593:2007 specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist therapy, including performance, quality assurance and user training and procedures for the verification and validation of performance by the intended users under actual and simulated conditions of use.ISO 17593:2007 pertains solely to prothrombin time measuring systems used by individuals for monitoring their own vitamin-K antagonist therapy, and which report results as international normalized ratios (INR).ISO 17593:2007 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.ISO 17593:2007 does not

• pertain to in vitro measuring systems for coagulation quantities assessing vitamin-K antagonist therapy used by physicians or healthcare providers,
• provide a comprehensive evaluation of all possible factors that could affect the performance of these systems, or
• address the medical aspects of oral anticoagulation therapy.

标准预览图