DANSK DS/ISO 17593 PDF

This International Standard 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. This International Standard 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). 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 the performance of these systems. This International Standard does not: – pertain to in vitro measuring systems for vitamin-K antagonist therapy used by physicians or health care providers; – provide a comprehensive evaluation of all possible factors that could affect the performance of these systems; – address the medical aspects of oral-anticoagulation therapy.