SIST EN 61223-3-4:2002
(Main)Evaluation and routine testing in medical imaging departments -- Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment
General Information
- Abstract
Applies to the performance of the acceptance test on dental X-ray equipment with intra-oral X-ray image receptor and dental X-ray equipment with extra-oral X-ray image receptor (for example, dental panoramic X-ray equipment or cephalometric X-ray equipment). Defines: - the essential parameters which describe the performance of the above-mentioned dental X-ray equipment with regard to imaging properties and patient dose; - methods of testing and wether measured quantities related to those parameters comply with the specified tolerances.
- Status
- Published
- Publication Date
- 31-Jan-2002
- Technical Committee
- IEMO - Electrical equipment in medical practice
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 01-Feb-2002
- Due Date
- 01-Feb-2002
- Completion Date
- 01-Feb-2002
- Directive
- 93/42/EEC - Medical devicesOJ Ref: C 173/2 OJ Date: 26-Jul-2006
Overview
EN 61223-3-4:2000 is a CLC (European) standard for acceptance tests of dental X‑ray equipment. It applies to dental systems using intra‑oral receptors and extra‑oral receptors (for example, dental panoramic and cephalometric X‑ray equipment). The standard defines the essential imaging‑performance parameters and patient‑dose considerations to be measured at acceptance, and describes test methods and criteria to determine compliance with specified tolerances.
Key Topics
- Scope and purpose
- Acceptance testing in medical imaging departments for dental radiography equipment.
- Equipment covered
- Dental intra‑oral X‑ray units and extra‑oral systems such as panoramic and cephalometric equipment.
- Performance parameters
- Imaging properties (image quality indicators) and patient dose metrics are defined as essential parameters.
- Test methods
- Standardized methods for measuring the defined parameters and assessing whether measured quantities meet tolerance limits.
- Compliance
- Criteria for pass/fail decisions at the time of equipment acceptance.
Practical Applications
- Clinical commissioning
- Use EN 61223-3-4 when accepting new or relocated dental X‑ray equipment to ensure imaging quality and radiation safety before clinical use.
- Quality assurance (QA) programs
- Incorporate acceptance test procedures from this standard into QA workflows for routine verification and baseline documentation.
- Radiation protection
- Assess patient dose performance at acceptance to support compliance with radiation safety regulations and optimization of exposures.
- Procurement and field testing
- Provide objective acceptance criteria for procurement teams, medical physicists, and service engineers during delivery and installation.
Who Uses This Standard
- Medical physicists performing acceptance and commissioning tests.
- Dental radiographers and clinicians responsible for equipment safety and image quality.
- Equipment manufacturers and installers to demonstrate conformity at handover.
- Regulators and accreditation bodies referencing standardized acceptance procedures during inspections.
- Biomedical engineers and maintenance teams for baseline measurements and troubleshooting.
Related Standards
- Standards for routine testing and ongoing quality control in medical imaging (other parts of EN 61223 series).
- National radiation protection regulations and dental radiography guidance documents.
EN 61223-3-4 is essential for ensuring that dental X‑ray equipment meets defined imaging performance and patient‑dose expectations at acceptance, supporting safe, high‑quality dental radiography and regulatory compliance.
Relations
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Effective Date
- 03-Feb-2026
- Refers
SIST EN 60336:1998 - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots - Effective Date
- 03-Feb-2026
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Frequently Asked Questions
SIST EN 61223-3-4:2002 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Evaluation and routine testing in medical imaging departments -- Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment". This standard covers: Applies to the performance of the acceptance test on dental X-ray equipment with intra-oral X-ray image receptor and dental X-ray equipment with extra-oral X-ray image receptor (for example, dental panoramic X-ray equipment or cephalometric X-ray equipment). Defines: - the essential parameters which describe the performance of the above-mentioned dental X-ray equipment with regard to imaging properties and patient dose; - methods of testing and wether measured quantities related to those parameters comply with the specified tolerances.
Applies to the performance of the acceptance test on dental X-ray equipment with intra-oral X-ray image receptor and dental X-ray equipment with extra-oral X-ray image receptor (for example, dental panoramic X-ray equipment or cephalometric X-ray equipment). Defines: - the essential parameters which describe the performance of the above-mentioned dental X-ray equipment with regard to imaging properties and patient dose; - methods of testing and wether measured quantities related to those parameters comply with the specified tolerances.
SIST EN 61223-3-4:2002 is classified under the following ICS (International Classification for Standards) categories: 11.040.50 - Radiographic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 61223-3-4:2002 has the following relationships with other standards: It is inter standard links to SIST HD 501 S1:1998, SIST EN 61267:1995, SIST EN 60601-2-28:1995, SIST EN 60522:2002, SIST EN 60601-1:1995, SIST EN 60417-2:2002, SIST EN 60336:1998. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 61223-3-4:2002 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN 61223-3-4:2002 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipmentBewertung und routinemäßige Prüfung in Abteilungen für medizinische Bildgebung -- Teil 3-4: Abnahmeprüfungen - Leistungsmerkmale zur Bildgebung von zahnärztlichen RöntgeneinrichtungenEssais d'évaluation et de routine dans les services d'imagerie médicale -- Partie 3-4: Essais d'acceptation - Performance d'imagerie des appareils de radiographie dentaireEvaluation and routine testing in medical imaging departments -- Part 3-4: Acceptance tests - Imaging performance of dental X-ray equipment11.040.50Radiografska opremaRadiographic equipmentICS:Ta slovenski standard je istoveten z:EN 61223-3-4:2000SIST EN 61223-3-4:2002en01-februar-2002SIST EN 61223-3-4:2002SLOVENSKI
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