Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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.
The 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 document is available in electronic format only.
Date of Publication: April 1, 2007
Order Code PDF: ISO17593E
Order Code Print: print not available
ISO 17593:2007 Additional Details
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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems