BS ISO 17593:2007 PDF

BS ISO 17593 is an international standard for manufacturers of in vitro medical devices, and other organizations such as regulatory authorities and conformity assessment bodies who have responsibility for assessing the performance of those systems. BS ISO 17593 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. The BS 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). BS 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 • Address the medical aspects of oral-anticoagulation therapy. Contents of BS include: Terms and definitions Design and development General requirements Measuring interval Safety Risk management and assessment Ergonomic and human factor aspects Quality assurance and risk controls Measurement verification Control of system performance Verification of self-testing performance