Codes et normes - Achat
détails du produit
ISO 17593:2007 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).
ISO 17593:2007 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.
ISO 17593:2007 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.