ISO 17593:2022
Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

Standard No.

ISO 17593:2022

Release Date

2022

Published By

International Organization for Standardization (ISO)

Latest

ISO 17593:2022

Scope

This document 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. This document applies solely to prothrombin time measuring systems used by lay persons for monitoring their own vitamin-K antagonist oral anticoagulation therapy, and which report results as international normalized ratios (INR). This document 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 document 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.

ISO 17593:2022 Referenced Document

• EN 13532 General requirements for in vitro diagnostic medical devices for self-testing
• IEC 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broad-band random and guidance
• IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*， 2024-04-21 Update
• IEC 61000-4-2 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measuring techniques - Electrostatic discharge immunity test
• IEC 61000-4-3 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
• IEC 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
• IEC 61010-2-101:2015 Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
• IEC 61326-1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
• IEC 61326-2-6 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
• ISO 13485 
• ISO 14971 Medical devices - Application of risk management to medical devices
• ISO 15198 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
• ISO 17511 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples
• ISO 18113-1 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements*， 2022-10-06 Update
• ISO 18113-4 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing*， 2022-10-06 Update
• ISO 18113-5 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing*， 2022-10-06 Update
• ISO 20916 In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
• ISO 23640 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents

ISO 17593:2022 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