ISO 23450:2021

ISO 23450:2021 - Dentistry - Intraoral camera

Overview

ISO 23450:2021 specifies requirements and test methods for intraoral cameras used in dentistry to capture pictorial representations of the oral cavity that support diagnosis and patient communication. The standard covers technical requirements, measurement and test methods, instructions for use, marking and labelling. It excludes several specialized camera types (see Scope).

Keywords: ISO 23450:2021, intraoral camera, dentistry standard, image quality, dental imaging, test methods, biocompatibility.

Key topics and technical requirements

ISO 23450 defines measurable performance and safety characteristics for intraoral cameras, including:

• General requirements and classification for intraoral camera handpieces and operator-side equipment.
• Biocompatibility and reprocessing requirements aligned with medical device risk management.
• Usability and human factors to support safe operation and patient communication.
• Protection from hazardous radiation and photobiological safety considerations.
• Image quality metrics:
  • Resolving power (expressed in line pairs per millimetre, lp/mm) and contrast transfer function (CTF, 20 % reference).
  • Dynamic range, vignetting and distortion.
  • Illumination performance specific to intraoral imaging.
• Optical characteristics: angular field of view, direction of view, working range and depth of field.
• Performance characteristics: image resolution, latency, autofocus performance, signal-to-noise ratio (SNR), pixel error limits, compression artefact assessment and frame rate.
• Test methods and reporting: standardized measurement procedures, sampling guidance, and required test report elements.
• Instructions for use, maintenance and marking to ensure traceability and correct clinical application.

The scope explicitly excludes devices such as medical endoscopes, CAD/CAM scanner handpieces, camera-equipped dental instruments for tooth colour determination, endodontic microcameras and similar specialized equipment.

Applications and practical value

ISO 23450 helps dental manufacturers, regulatory teams and clinical users by:

• Providing objective test methods and pass/fail criteria to validate intraoral camera performance.
• Ensuring consistent image quality for diagnosis, documentation and patient education.
• Supporting product development, conformity assessment and market entry by aligning devices with recognized international requirements.
• Improving usability and cleaning/reprocessing instructions to reduce infection risk and enhance clinical workflow.

Who should use this standard

• Medical device manufacturers and R&D teams designing intraoral cameras.
• Quality, regulatory and compliance professionals preparing technical files and conformity documentation.
• Dental clinics and procurement teams evaluating intraoral camera performance and safety.
• Test laboratories performing performance validation and certification.

Related standards

Normative references include ISO 1942, ISO 10993-1, ISO 17664, IEC 60601-1, IEC 60601-1-6, IEC 62366-1, IEC 62471 and IEC 80601-2-60 - all relevant for safety, usability, biocompatibility and photobiological assessment.