Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

رقم المستند: NL ISO 17593 : 2011
القطاع: Health Care Technology
TC: NL TC 212
ICS: 11.100.20
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 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