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

ISO 17593:2007

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. 

This document is available in electronic format only. 

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Publication Details

Date of Publication: April 1, 2007

Order Code PDF: ISO17593E

Order Code Print: print not available

Edition: First

Pages: 54

ISO 17593:2007 Additional Details

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). 

Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems