EN 61262-4:1994

Overview

EN 61262-4:1994 (CLC) - Medical electrical equipment - Characteristics of electro‑optical X‑ray image intensifiers - Part 4: Determination of the image distortion - is a European adoption of IEC 1262-4:1994. The standard applies to electro‑optical X‑ray image intensifiers used as components in diagnostic X‑ray equipment and describes a method for measuring and reporting image distortion. It establishes a common basis for assessing geometric fidelity of intensifiers in clinical imaging chains.

Key topics and requirements

The document focuses on practical measurement and characterization rather than design limits. Key technical topics include:

• Scope and definitions relevant to electro‑optical X‑ray image intensifiers and image distortion terminology.
• Methodology for determining image distortion, specifying a standardized approach to measure geometric distortions produced by the intensifier.
• Test arrangement and equipment - general requirements for the test setup (e.g., use of suitable test patterns/phantoms, imaging geometry and acquisition conditions) to ensure repeatable measurements.
• Measurement procedure - steps to acquire test images, detect reference points or grid markers, and calculate distortion across the image field.
• Data analysis and reporting - how to express distortion results (qualitative maps and quantitative values), document test conditions, and present findings for traceability and comparison.
• Acceptance and repeatability considerations - guidance on ensuring reproducible results and identifying significant deviations that may affect diagnostic use.

(Note: the standard specifies methods and reporting requirements; specific numeric limits or formulae are contained in the official text.)

Applications and users

EN 61262-4:1994 is directly useful for:

• Medical device manufacturers - validating and characterizing image intensifier performance during development and production testing.
• Independent test laboratories and certification bodies - performing compliance testing and performance verification.
• Clinical engineers and medical physicists - acceptance testing, periodic quality assurance (QA), and maintenance of diagnostic X‑ray systems.
• Hospital procurement and regulatory reviewers - evaluating vendor specifications and ensuring equipment meets expected imaging performance for patient care.

Practical benefits include improved geometric accuracy in fluoroscopic and radiographic imaging, consistent QA procedures, and clearer documentation for regulatory compliance.

Related standards

• IEC 1262-4:1994 - original international document equivalent to EN 61262-4:1994.
• Other parts of the EN/IEC 61262 series covering additional characteristics of X‑ray image intensifiers and related test methods.
• National adoptions (e.g., SIST EN 61262-4:1995) reflect local publishing and copyright considerations.

Keywords: EN 61262-4:1994, image distortion, X‑ray image intensifiers, electro‑optical, medical electrical equipment, determination of the image distortion, diagnostic X‑ray equipment, IEC 1262-4.