IEC 61223-3-5-2019 PDF

Full title and description

IEC 61223-3-5:2019 — Evaluation and routine testing in medical imaging departments — Part 3-5: Acceptance and constancy tests — Imaging performance of computed tomography X‑ray equipment. The document defines essential performance parameters for CT scanners (image quality, radiation output/patient dose and patient positioning), specifies test methods for acceptance and constancy testing, and provides criteria for evaluating compliance with tolerances and accompanying documents.

Abstract

This part of IEC 61223 describes non‑invasive test methods and measurement procedures to verify that a computed tomography (CT) installation meets specified performance requirements affecting image quality, radiation output and patient positioning. It is intended for use during equipment installation (acceptance) and for periodic constancy checks, and it references requirements in IEC 60601‑2‑44 and related documents.

General information

• Status: International standard — current edition IEC 61223-3-5:2019 (with later corrigendum).
• Publication date: 2019 (published/issued as IEC 61223-3-5:2019; some national/adopted editions list 01 Dec 2019).
• Publisher: International Electrotechnical Commission (IEC), TC 62 / SC 62B.
• ICS / categories: 11.040.50 (Radiographic equipment / medical imaging).
• Edition / version: Edition 2.0 (IEC 61223-3-5:2019); corrigendum available (IEC 61223-3-5:2019/COR1:2022).
• Number of pages: Approximately 65–70 pages depending on publisher/format (industry catalogues commonly list ~70 pages for the 2019 edition).

Scope

IEC 61223-3-5:2019 applies to CT scanners covered by IEC 60601‑2‑44 and specifies the essential parameters and associated test methods for acceptance and constancy testing of CT imaging performance. It covers image quality measurements, assessment of radiation output/patient dose, and checks for correct patient positioning — using primarily non‑invasive measurements and appropriate test equipment — to verify that installations comply with performance tolerances and accompanying documents.

Key topics and requirements

• Definition of essential CT performance parameters (image quality metrics, artifacts, uniformity, spatial resolution, contrast resolution).
• Procedures for measuring radiation output and patient dose indicators (e.g., CTDI and other relevant dose quantities) as part of acceptance/constancy tests.
• Patient positioning checks and alignment tests to confirm geometric accuracy and table movement.
• Acceptance test protocols, pass/fail tolerances and the structure of test reports (including use of signed installation statements where applicable).
• Reference to related safety and performance standards (for example IEC 60601‑2‑44) and use of non‑invasive test instruments and phantoms.

Typical use and users

Primary users include medical physicists, clinical engineers, hospital biomedical/medical device teams, CT service engineers, regulatory bodies and test laboratories performing equipment acceptance testing, commissioning and routine constancy checks in radiology departments. The standard is used to structure acceptance test procedures, interpret measured results against tolerances, and document compliance during installation and periodic quality assurance.

Related standards

IEC 61223-3-5 is part of the IEC 61223 family (Evaluation and routine testing in medical imaging departments). It is commonly used together with IEC 60601-2-44 (particular safety and performance standard for CT equipment) and other IEC 61223 parts (e.g., Part 1 general aspects and other Part 3 documents covering radiography, mammography, DSA and dental equipment). Corrigenda and national/adopted (EN/UNE/etc.) versions and amendments (for example the 2019 corrigendum issued in 2022) should also be consulted.

Keywords

CT, computed tomography, acceptance testing, constancy tests, image quality, patient dose, CTDI, IEC 61223, IEC 60601-2-44, medical imaging QA, test phantom, clinical engineering.

FAQ

Q: What is this standard?

A: IEC 61223-3-5:2019 is the international standard that specifies acceptance and constancy test procedures for the imaging performance of computed tomography (CT) X‑ray equipment. It describes which parameters to test, how to measure them and how to evaluate compliance.

Q: What does it cover?

A: It covers test methods and performance parameters related to CT image quality (spatial and contrast resolution, artifacts, uniformity), radiation output/patient dose measurements, and patient positioning/geometry checks used during acceptance and routine quality assurance. Tests are mainly non‑invasive and rely on appropriate phantoms and measurement instruments.

Q: Who typically uses it?

A: Medical physicists, hospital clinical/biomedical engineering teams, CT service engineers, QA personnel and testing laboratories use this standard to perform and document acceptance, commissioning and periodic constancy checks for CT scanners. Regulators and accreditation bodies may reference it for compliance checks.

Q: Is it current or superseded?

A: The 2019 edition (IEC 61223-3-5:2019) superseded the 2004 edition; the 2004 edition was withdrawn when the 2019 edition became the main publication. A corrigendum for the 2019 edition (COR1:2022) has been issued. Users should check for any further amendments, national adoptions or later revisions when applying the standard.

Q: Is it part of a series?

A: Yes — IEC 61223 is a multipart series covering evaluation and routine testing in medical imaging departments. Part 3 comprises several subparts (3-1, 3-2, 3-3, 3-4, 3-5, etc.), each addressing acceptance tests for different imaging modalities; Part 1 covers general aspects and other Part 2/Part 3 documents cover constancy and modality‑specific tests.

Q: What are the key keywords?

A: CT, computed tomography, acceptance tests, constancy tests, image quality, patient dose, CTDI, IEC 61223, IEC 60601‑2‑44, medical imaging QA.