EN ISO 15194:2026 PDF

Overview

EN ISO 15194:2026 sets out the essential requirements for certified reference materials (CRMs) used in in vitro diagnostic (IVD) medical devices, with a focus on higher metrological order CRMs and their supporting documentation. This standard was developed by CEN, adopting the content of ISO/FDIS 15194:2026, and aligns closely with ISO 17511:2020, which details calibration hierarchies and traceability structures in laboratory medicine. The updated 2026 edition clarifies definitions, strengthens requirements for documentation, and standardizes how certified reference values, uncertainties, and intended uses are reported.

The goal is to assure accuracy and traceability in IVD measurement results, which is vital for patient safety, clinical decision-making, and regulatory compliance. The standard guides CRM producers and users in laboratory medicine, ensuring that reference materials deliver reliable, consistent, and harmonized results across diverse analytical systems.

Key Topics

• Certified Reference Materials (CRMs):

  • CRMs are highly characterized materials with specified property values and uncertainties, supporting traceability to recognized measurement standards.
  • They serve as primary reference materials, secondary calibrators, or trueness controls in calibration hierarchies.

• Supporting Documentation:

  • The standard details the required content for reference material certificates and certification reports.
  • Required documentation includes information on material source, processing, characterization, measurement results, traceability, certified values, uncertainty calculations, safety information, and instructions for use.

• Calibration Hierarchies:

  • CRMs act as anchor points in calibration hierarchies, ensuring metrological traceability of routine laboratory measurements to higher-order references described in ISO 17511:2020.
  • Descriptions must clarify a CRM’s place and role within these hierarchies.

• Commutability and Intended Use:

  • The commutability of CRMs (their ability to behave like patient samples across measurement systems) is critically assessed and documented.
  • Intended clinical use, matrix properties, and any limitations in application are to be clearly reported.

• Certified Value Assignment & Uncertainty:

  • Outlines rigorous procedures for establishing certified values for each measurand, including methods for evaluation and reporting of measurement uncertainty.
  • Ensures results are accurate and reliable for calibration and trueness assessment purposes.

Applications

EN ISO 15194:2026 is vital for:

• Producers of Certified Reference Materials:

  • Guidance on the design, production, value assignment, and documentation of CRMs for IVD applications.
  • Standardizes evaluation of homogeneity, stability, traceability, and uncertainty.

• Clinical Laboratories & Diagnostic Manufacturers:

  • Ensures that calibration systems and trueness controls used in lab medicine meet international requirements.
  • Supports compliance with European regulations, such as the In Vitro Diagnostic Regulation (IVDR - Regulation (EU) 2017/746).

• Regulatory Authorities & Assessors:

  • Provides a harmonized baseline for assessment of CRM quality, documentation, and traceability claims in conformity assessment and market surveillance processes.

• End Users & Quality Managers:

  • Assures laboratory professionals that reference materials used for calibration, proficiency testing, or method validation meet recognized benchmarks for reliability and support valid medical decisions.

Related Standards

• ISO 17511:2020 In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (Defines calibration hierarchies and traceability concepts referenced by EN ISO 15194:2026)

• ISO 17034 General requirements for the competence of reference material producers

• ISO 15193 In vitro diagnostic medical devices - Measurement procedures for quantities in biological samples

• ISO/IEC Guide 99:2007 International vocabulary of metrology - Basic and general concepts and associated terms

These standards collectively ensure global harmonization, reliability, and safe application of reference materials in IVD medical testing environments. By adhering to EN ISO 15194:2026, organizations can demonstrate commitment to best practices in clinical measurement, traceability, and documentation integrity.