BS ISO 17593:2022 PDF

Scope: What is ISO 17593 - Oral-anticoagulation monitoring systems about? ISO 17593 discusses clinical laboratory testing and in-vitro medical devices. ISO 17593 specifies requirements for in vitro measuring systems for self-monitoring of vitamin-K antagonist oral anticoagulation therapy, including performance, quality assurance and user training and procedures for the validation of performance by the intended users under actual and simulated conditions of use. ISO 17593 applies solely to prothrombin time measuring systems used by laypersons for monitoring their own vitamin-K antagonist oral anticoagulation therapy, which reports results as international normalized ratios (INR). Note: ISO 17593 is not applicable to: In vitro measuring systems for coagulation quantities assessing vitamin-K antagonist oral anticoagulation therapy used by physicians or healthcare providers Non-vitamin-K antagonist oral anticoagulation therapy (e.g., dabigatran) A comprehensive evaluation of all possible factors that can affect the performance of these systems The medical aspects of oral-anticoagulation therapy ...

BS ISO 17593:2022 history

2022 BS ISO 17593:2022 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
2007 BS ISO 17593:2007 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy