EN ISO 15193:2026 PDF

Overview

EN ISO 15193:2026 sets out critical requirements for reference measurement procedures (RMPs) used in laboratory medicine for in vitro diagnostic (IVD) medical devices. Developed by CEN, this international standard ensures the consistency and reliability of measurement results by defining the structure and quality criteria for RMPs, which underpin metrological traceability and accuracy in laboratory diagnostics. The standard is applicable to RMPs involving differential or rational quantities, as well as any parties involved in developing such procedures for medical laboratory measurands.

By offering a clear framework for reference measurement, EN ISO 15193:2026 helps laboratories, device manufacturers, and regulatory authorities achieve harmonized and comparable measurement results, contributing directly to improved patient safety and quality standards across healthcare systems.

Key Topics

EN ISO 15193:2026 focuses on several essential areas to uphold the integrity of reference measurement procedures in the context of in vitro diagnostics:

• Scope and Definitions: Clarifies terminology and the boundaries of RMPs, including what constitutes a measurand, analyte, and the types of quantities addressed.
• Elements of a Reference Measurement Procedure: Details the required content and presentation for RMPs, such as:
  • Measurement principles and methods
  • Reagents, calibrators, and materials used
  • Sampling and sample preparation
  • Description and validation of the measuring system
  • Calibration, operation, and analytical workflow
  • Data processing, calculation, and reporting protocols
• Validation and Quality Assurance: Sets requirements for verifying measurement trueness, precision, detection limits, use of reference materials, interlaboratory comparisons, and documentation of measurement uncertainty.
• Reporting and Traceability: Provides guidance for ensuring results are traceable to recognized standards and reported transparently for regulatory and clinical use.
• Special Cases and Annexes: Addresses nominal properties, ordinal quantities, and the relationship with European regulations such as the General Safety and Performance Requirements under EU Regulation 2017/746.

Applications

EN ISO 15193:2026 delivers practical value for a range of users involved with laboratory medicine and in vitro diagnostic devices:

• Clinical and Medical Laboratories: Enables labs to develop, adopt, or validate RMPs ensuring measurement data is metrologically traceable, accurate, and comparable across different systems and over time.
• IVD Manufacturers: Guides manufacturers in designing, validating, and documenting reference measurement procedures, which improves product reliability and meets regulatory submission requirements.
• Regulatory and Accreditation Bodies: Provides a harmonized benchmark for assessing the adequacy of RMPs during audits, certifications, and market approval processes.
• Reference Materials Producers: Assists organizations in developing or certifying reference standards to support calibration hierarchies outlined in ISO 17511.
• Research and Development: Supports researchers striving for high-quality, traceable measurement results in laboratory medicine, fostering comparability and reproducibility in medical research.

Related Standards

EN ISO 15193:2026 is designed to align with and complement several other international standards, creating a cohesive framework for laboratory medicine and in vitro diagnostics:

• ISO 17511:2020: Requirements for establishing metrological traceability of values assigned to calibrators, control materials, and human samples.
• ISO 15194: Requirements for certified reference materials in laboratory medicine.
• ISO 15195: Specifies requirements for reference measurement laboratories.
• ISO/IEC Guide 99: International vocabulary of metrology for standardized terms and definitions.
• ISO/IEC Guide 98-3: Guide to the expression of uncertainty in measurement.

Implementation of EN ISO 15193:2026 ensures the highest standard of quality, reliability, and traceability in laboratory medicine globally, supporting safe and effective clinical decision-making through trustworthy in vitro diagnostic test results.