ISO 17593:2007
Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
- Standard No.
- ISO 17593:2007
- Release Date
- 2007
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 17593:2022
- Latest
- ISO 17593:2022
- Scope
- 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 International 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 International Standard 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. This International Standard 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.
ISO 17593:2007 Referenced Document
- EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
- EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
- EN 13640:2002 Stability Testing of in Vitro Diagnostic Reagents
- IEC 60068-2-64:1993 Environmental testing; part 2: test methods; test Fh: vibration, broad-band random (digital control) and guidance
- IEC 61000-4-2:1995 Electromagnetic compatibility (EMC) - Part 4: Testing and measuring techniques - Section 2: Electrostatic discharge immunity test - Basic EMC publication
- IEC 61000-4-3:2006 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
- IEC 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
- IEC 61326:2002 Electrical equipment for measurement, control and laboratory use - EMC requirements
- ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
- ISO 14971:2007 Medical devices - Application of risk management to medical devices
- ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
- ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
- ISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements*， 2009-12-01 Update
- ISO 18113-4:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing*， 2009-12-01 Update
- ISO 18113-5:2009 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing*， 2009-12-01 Update
ISO 17593:2007 history
- 2022 ISO 17593:2022 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
- 2007 ISO 17593:2007 Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
