BS ISO 17593 is an international standard for manufacturers of in vitro medical devices, and other organizations such as regulatory authorities and conformity assessment bodies who have responsibility for assessing the performance of those systems.
BS ISO 17593 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 BS ISO 17593 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).
BS ISO 17593 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
• Address the medical aspects of oral-anticoagulation therapy.
Contents of BS ISO 17593 include:Terms and definitions
Design and development
General requirements
Measuring interval
Safety
Risk management and assessment
Ergonomic and human factor aspects
Quality assurance and risk controls
Measurement verification
Control of system performance
Verification of self-testing performance
Evaluation of user compliance in following the manufacturer’s and the physician’s instructions
Metrological traceability
Information supplied by the manufacturer
Labels for reagents, control material and the oral-anticoagulation monitoring instrument
Instructions for use of the oral-anticoagulation monitoring system
Protocol
Instruments and reagents
Acceptance criteria
Protection against mechanical hazards and electric shock
Electromagnetic compatibility
Resistance to heat, moisture and liquids
Protection against liberated gases, explosion and implosion
Instrument components
Performance test
Protocols for vibration and drop tests
Temperature exposure limits
High- and low-temperature test protocol
Humidity-exposure test protocol
Reagent storage and use testing
Training and education programs
Training of healthcare providers
Education of patients and other users
System performance verification
Contributors to measurement uncertainty
System performance verification study
Verification of measurement precision and repeatability
Data analysis
Verification of system accuracy
Instruments and reagents
Manufacturer’s selected measurement procedure
Study design
Procedure
Data analysis
Minimum acceptable system accuracy
System accuracy requirement and assessment
Data presentation
User performance evaluation
Study sites
Subjects
Instruments and materials
Evaluation of user proficiency
Acceptance criteria and data assessment
Evaluation of instructions for use
Oral-anticoagulation monitoring systems are in vitro diagnostic medical devices that measure prothrombin time in fresh, unmodified human blood samples. Prothrombin time is an indicator of the ability of blood to clot.
In vitro diagnostic 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. Patients must maintain the level of anticoagulant in the blood high enough to reduce thrombin formation, yet low enough to avoid excessive bleeding. An oral-anticoagulation monitoring system allows the user to monitor anticoagulation therapy and take action to control the level of anticoagulant present in the blood.
BS ISO 17593 applies to oral-anticoagulation monitoring systems to be used by lay persons. The primary objectives are to establish requirements for oral-anticoagulation monitoring systems that will enable lay users to achieve acceptable performance, and to specify procedures for manufacturers and other interested parties to demonstrate conformance of such systems to this standard.
Performance criteria for oral-anticoagulation monitoring systems were established, based on the state-of-the art, which has been shown to offer significant benefit to patients. The criteria are given in terms of “system accuracy”, because metrological terms commonly used in International Standards (e.g., trueness and measurement uncertainty) would not be familiar to lay users. System accuracy, which is affected by systematic bias and random effects (and is inversely related to measurement uncertainty), describes the degree to which the individual results produced by an oral-anticoagulation monitoring system agree with correct INR values when the system is used as intended by lay persons.
In setting the performance criteria, it is assumed that users will be properly selected and will receive the necessary training; that the device will be properly maintained, and that operating and control procedures will be followed in accordance with the manufacturer’s instructions for use. It is also assumed that manufacturers will anticipate and mitigate the effects of reasonably foreseeable misuse, including reasonably foreseeable deviations from recommended maintenance, operating and control procedures by the intended users.
Requirements that are unique to self-testing with oral-anticoagulation monitoring systems, including specific content of information supplied by the manufacturer, are addressed in this International Standard. General requirements that apply to all in vitro diagnostic medical devices and are covered by other standards (e.g., IEC 61010, ISO 13485, ISO 14971 and ISO 18113) are incorporated by reference, where appropriate. In addition, national regulations may apply.
