ISO 15194:2026

Overview

ISO 15194:2026 establishes internationally recognized requirements for certified reference materials (CRMs) used in in vitro diagnostic (IVD) medical devices. As a critical document in laboratory medicine, this standard specifies the quality criteria for CRMs of higher metrological order and details the content required in supporting documentation. By aligning with ISO 17511:2020, ISO 15194:2026 ensures that calibration hierarchies and metrological traceability are consistently applied, enhancing the reliability and comparability of medical laboratory results.

Key Topics

• Certified Reference Materials (CRMs): Defines the essential characteristics and quality requirements for CRMs, including their use as primary reference materials (PRMs), secondary calibrators, and international conventional calibrators.
• Supporting Documentation: Specifies the required content for labels, reference material certificates, and certification reports to ensure transparency, traceability, and appropriate use of CRMs.
• Calibration Hierarchies: Outlines the roles of CRMs within established calibration hierarchies, as described in ISO 17511:2020, supporting consistent measurement results across laboratory medicine.
• Certified Value Assignment: Details the processes for determining certified values, including thorough evaluation and reporting of measurement uncertainty.
• Measurands and Quantitative Values: Provides guidance on CRMs with assigned property values that can be expressed as quantitative values or ratios, and discusses consistency when multiple measurands are included in a CRM.
• Commutability: Emphasizes the importance of commutability assessment, especially when CRMs are used as secondary calibrators, ensuring CRMs perform reliably across different measurement procedures.
• Trueness Controls: Describes how CRMs function as trueness controls in measurement procedures, supporting the assessment of measurement accuracy.

Applications

ISO 15194:2026 provides practical value to several stakeholders in the medical laboratory community:

• Producers of CRMs: Offers comprehensive guidance on the production, characterization, and documentation of high-quality CRMs to meet regulatory and market needs.
• Medical Laboratories: Supports laboratories in verifying the performance of IVD measurement procedures, achieving accurate and traceable results essential for patient care.
• IVD Manufacturers: Serves as a benchmark for assessing the performance and suitability of CRMs and other reference materials in product development, calibration, and quality control.
• Regulatory Authorities: Facilitates the consistent evaluation of CRMs and their supporting documentation, contributing to harmonized international practices and patient safety.
• Quality Assurance: Enhances metrological traceability and measurement reliability in laboratory medicine, thereby strengthening the quality assurance systems of organizations using in vitro diagnostic devices.

Related Standards

For comprehensive traceability and quality in laboratory measurements, ISO 15194:2026 references and complements several 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.
• ISO 17034 – General requirements for the competence of reference material producers.
• ISO/IEC Guide 99 (VIM) – International vocabulary of metrology - Basic and general concepts and associated terms.
• ISO 15193 – Requirements for higher order reference measurement procedures.

Conclusion

ISO 15194:2026 is an essential part of the international framework designed to ensure the reliability and accuracy of measurement results in laboratory medicine. By specifying rigorous requirements for certified reference materials and their documentation, the standard supports patient safety, measurement consistency, and quality improvement for all users and producers of IVD reference materials. Adherence to ISO 15194:2026 facilitates global harmonization and fosters confidence in diagnostic measurements used in medical decision-making.