Overview
ISO 15193:2026 - In vitro diagnostic medical devices - Requirements for reference measurement procedures is an international standard developed by ISO (International Organization for Standardization). This document specifies the requirements for reference measurement procedures (RMP) applicable to laboratory medicine. These procedures are central to ensuring the accuracy, reliability, and metrological traceability of results for differential or rational quantities in in vitro diagnostic (IVD) medical devices.
The standard targets any individual, institution, or body developing reference measurement procedures for measurands in laboratory medicine. It supports harmonization across laboratories by detailing how RMPs should be established, validated, and maintained, directly impacting patient care and clinical decision-making through high-quality laboratory results.
Key Topics
ISO 15193:2026 covers essential elements to guarantee the quality and consistency of reference measurement procedures:
- Scope and Definitions: Provides clear terminology and scope regarding RMPs in laboratory medicine, crucial for consistent communication and implementation.
- Elements of a Reference Measurement Procedure: Outlines requirements for:
- Measurement principles and methods
- Reagents and materials characterization
- Apparatus and equipment descriptions
- Sampling and sample preparation
- Validation and Calibration: Defines procedures for calibration, analytical series design, analytical portion handling, and solution preparation.
- Data Processing and Reporting:
- Calculation methods for measurement results
- Conversion equations for measurement units
- Accurate and transparent reporting of results
- Performance Parameters: Specifies requirements for verifying:
- Analytical sensitivity and selectivity
- Measurement trueness, precision, limit of detection, and uncertainty
- Analytical influence quantities, blanks, and carry-over effects
- Validation using reference materials and interlaboratory comparisons
- Quality Assurance: Details ongoing requirements for maintaining high-quality measurement processes, with emphasis on documentation and periodic review.
Annex A of the standard provides additional guidance on procedures for ordinal quantities and nominal properties, expanding the applicability of the document.
Applications
Implementing ISO 15193:2026 offers broad practical benefits in laboratory medicine and the IVD sector:
- Development of Reference Methods: Offers structured requirements for creating reliable RMPs that serve as the benchmark for routine assays and measurement systems.
- Metrological Traceability: Enables laboratories and manufacturers to demonstrate traceability of results to recognized standards, supporting compliance with regulatory and accreditation requirements.
- Calibration and Trueness Control: Facilitates the assignment of quantity values to reference materials, which are vital for calibration of IVD devices and ongoing trueness control.
- Interlaboratory Harmonization: Supports equivalence and comparability of measurement results across different laboratories, underlying global health and patient safety initiatives.
- Validation of Measurement Results: Guides laboratories and IVD manufacturers in designing validation protocols to ensure that measurement procedures meet performance specifications.
These applications contribute to improved patient outcomes, enhanced laboratory quality management, and global harmonization of laboratory medicine practices.
Related Standards
ISO 15193:2026 is interrelated with several other key standards in the field of laboratory medicine and metrology:
- ISO 17511 – Requirements for establishing metrological traceability in IVD medical devices
- ISO 15194 – Requirements for certified reference materials and their documentation
- ISO 15195 – Laboratory requirements for reference measurement laboratories
- ISO/IEC Guide 98-3 – Guide to the expression of uncertainty in measurement (GUM)
- ISO/IEC Guide 99 – International vocabulary of metrology (VIM)
Adherence to these standards together ensures robust metrological practices and high-quality results in medical laboratory settings.
By implementing ISO 15193:2026, laboratories and manufacturers contribute significantly to the reliability and global comparability of medical test results, supporting diagnostic confidence and patient safety worldwide.