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

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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

Who is ISO 17593 - Oral-anticoagulation monitoring systems for?

ISO 17593 on clinical laboratory testing and in-vitro medical devices is useful for:

  • Manufacturers of in-vitro medical devices
  • Quality control personnel
  • Regulatory authorities
  • Conformity assessment bodies

Why should you use ISO 17593 - Oral-anticoagulation monitoring systems?

Oral-anticoagulation monitoring systems are in vitro diagnostic (IVD) medical devices that measure prothrombin time in fresh, untreated human blood specimens. Prothrombin time is an indicator of the ability of blood to clot. IVD medical devices for self-testing of oral-anticoagulation therapy are used predominantly by individuals who have heart valve replacements, or who are suffering from atrial fibrillation or deep vein thrombosis and are receiving oral anticoagulant therapy with vitamin K antagonist medicines

ISO 17593 establishes requirements for oral-anticoagulation monitoring systems that will enable patients to achieve acceptable performance levels. ISO 17593 specifies procedures for manufacturers and other interested parties to demonstrate conformance of such systems to the requirements stated in it.

In conclusion, by adhering to the guidelines of ISO 17593 you can produce in-vitro medical devices that meet safety requirements and are user-friendly for the convenience of the patients.

What’s changed since the last update?

BS ISO 17593:2022 supersedes ISO 17593:2007, which has been technically revised.

The main changes are as follows:

  • Updated with more current state of the art information that has evolved over several years
  • Subclause 8.4 Validation of measurement precision: added a more robust study design
  • Subclause 8.5.8.2 and 8.5.8.3: updated examples were added to reflect changes in criteria
  • Subclause 8.6 Minimum acceptable system accuracy: Updated requirements/performance criteria
  • Clause 9 Layperson performance evaluation: added clarity, revised performance criteria and increased sample size