IEC 61267:2025

Overview

IEC 61267:2025 - Medical diagnostic X‑ray equipment - Radiation conditions for use in the determination of characteristics defines standardized X‑ray radiation conditions and methods for generating and verifying those conditions when testing medical diagnostic X‑ray systems and components. Intended for test laboratories and manufacturing facilities, this international standard ensures repeatable, well‑defined radiation qualities used to determine equipment characteristics, performance and compliance.

What’s new in the 2025 edition

This third edition (replacing IEC 61267:2005) is a technical revision that includes:

• Removal of the former Annex C on practical peak voltage measurement.
• Addition of informative tabulated values for the squared signal‑to‑noise ratio per air kerma (SNR2in).
• A normative annex with additional X‑ray radiation conditions for mammography and corresponding nominal aluminium half‑value layers (HVL).
• Revised X‑ray radiation conditions and a new method for verification of those conditions.
• Updated term definitions.

Key topics and technical requirements

• Defined X‑ray radiation conditions (RQR, RQA, RQC, RQT, RQN, RQB and modality‑specific Rxx‑M sets) used to characterize diagnostic X‑ray equipment.
• Generation and verification methods for each radiation condition, including geometry and added filtration requirements.
• Test instrumentation requirements, such as maximum inherent filtration, anode material, percentage ripple of X‑ray tube voltage, voltage measuring devices and radiation detectors.
• Measuring arrangements and procedures (Annex A normative) and methods for determining additional filtration (Annex B informative).
• Performance‑related data: tabulated SNR2in values (Annex C informative) to support image quality assessments per unit air kerma.
• Normative mammography conditions and guidance on aluminum HVL determination (Annex D).

Practical applications

IEC 61267:2025 is used to:

• Establish repeatable test conditions in production testing of X‑ray tubes and systems.
• Support type testing and performance characterization in independent test laboratories.
• Provide standardized radiation qualities for acceptance testing, calibration and quality assurance programs.
• Inform image quality and dose relationship studies (using SNR2in) and mammography‑specific evaluations.

Who should use this standard

• Medical device manufacturers (X‑ray equipment and tube suppliers)
• Calibration and conformity assessment laboratories
• Clinical engineers, medical physicists and QA teams
• Regulatory authorities and standards developers

Related standards

IEC 61267:2025 complements other IEC and ISO standards addressing X‑ray equipment safety, performance testing, and terminology. Users should ensure they consult the latest editions and applicable normative references cited within IEC 61267 when applying the standard.