EN 61223-3-4:2000

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.