ISO 17593:2022

Overview

ISO 17593:2022 specifies requirements for in vitro measuring systems used by lay persons to self-monitor vitamin‑K antagonist oral anticoagulant therapy. The standard covers prothrombin time (PT) measuring systems that report results as international normalized ratios (INR) and defines performance, quality assurance, user training, and procedures for validating performance under actual and simulated conditions of use. ISO 17593:2022 is intended for manufacturers and organizations (e.g., regulatory authorities, conformity assessment bodies) responsible for assessing these self‑testing systems. It does not apply to devices used by healthcare professionals, non‑vitamin‑K antagonist therapies (for example, dabigatran), or to clinical treatment decisions.

Key technical topics and requirements

• Design and development: General device design, measuring interval, safety, risk management, and human factors/ergonomics to support lay‑person use.
• Performance validation: Protocols for validating measurement precision (repeatability, intermediate precision) and system accuracy, including study design, comparator procedures, and data analysis.
• Quality assurance and metrological traceability: Requirements for measurement verification, control of system performance, and traceability to reference standards.
• Information and labeling: Requirements for instructions for use, reagent and control labeling, and user documentation tailored to lay persons.
• Safety and reliability testing: Electrical, mechanical, environmental (temperature, humidity), electromagnetic compatibility, and reagent storage/use testing. Annexes provide EMC requirements and traceability examples.
• User training and evaluation: Requirements for education programs for lay users and healthcare providers, and methods to evaluate lay‑person proficiency and adherence to instructions.
• Lay person performance evaluation: Protocols for real‑world and simulated studies to assess usability and clinical performance when used at home.

Practical applications

• Ensures self‑monitoring INR devices meet robust safety, accuracy, and usability criteria for home use.
• Guides manufacturers in product design, validation studies, labeling, and post‑market quality assurance.
• Supports regulatory and conformity assessment activities by providing objective criteria for approval and surveillance of self‑testing systems.
• Helps clinicians and patient programs evaluate device suitability for self‑management of vitamin‑K antagonist therapy.

Who should use this standard

• Medical device manufacturers of INR self‑testing systems
• Regulatory authorities and notified bodies assessing device conformity
• Clinical laboratories advising on device performance and traceability
• Healthcare providers and anticoagulation clinics implementing patient self‑monitoring programs

Related standards

ISO 17593 refers to ISO/IEC Directives and collaborates with IEC on electrotechnical matters; users should also consult applicable ISO and IEC standards on medical device safety, metrological traceability, and electromagnetic compatibility when implementing or assessing INR self‑testing systems.