Overview
EN ISO 23450:2021 (ISO 23450:2021) specifies requirements and test methods for intraoral cameras used in dentistry to produce pictorial representations of the oral cavity for diagnosis and patient information. Published by CEN/ISO in 2021, the standard covers technical requirements, test procedures, instructions for use, marking and labelling for intraoral camera devices intended for clinical use.
This standard applies to intraoral camera medical devices only and is not applicable to items such as powered polymerization activators, exclusively extraoral cameras, dental microscopes, medical endoscopes, transillumination handpieces, CAD/CAM scanner handpieces, endodontic/root-canal microcameras, tool-navigation cameras or tooth-colour determination cameras.
Key Topics and Requirements
EN ISO 23450:2021 defines measurable technical and safety characteristics including:
- Image quality: resolving power, dynamic range, illumination, vignetting and distortion, with test methods for visual performance and artefact assessment.
- Optical characteristics: angular field of view, direction of view, working range and depth of field.
- Performance characteristics: image resolution, latency, autofocus behaviour, signal-to-noise ratio (SNR), pixel error rates, compression artefacts and frame rate.
- Safety and usability: biocompatibility, usability, reprocessing (cleaning/sterilization), protection from hazardous radiation and ergonomic considerations.
- Documentation: requirements for instructions for use, maintenance information, marking and labelling, and a formal test report format.
- Test methods: detailed measurement procedures for image quality, optics and performance metrics, including sampling guidance and annex examples (e.g., compression artefacts).
Applications and Practical Value
EN ISO 23450:2021 provides a technical benchmark for reliable dental imaging and supports:
- Improved diagnostic imaging and consistent image quality in dental clinics.
- Clear product specifications for manufacturers developing or validating intraoral cameras.
- Objective performance testing by independent laboratories and regulatory bodies.
- Informed procurement decisions for dental practices and hospital departments seeking compliant intraoral camera systems.
- Better patient communication and documentation through standardized image outputs.
Keywords: EN ISO 23450:2021, intraoral camera, dentistry standard, dental imaging, image quality, test methods, medical device.
Who Would Use This Standard
- Dental device manufacturers and R&D teams
- Test laboratories and conformity assessment bodies
- Regulatory authorities and notified bodies in Europe
- Dental clinics and procurement managers
- Quality and compliance engineers in dental technology
Related Standards
- IEC 60601-1 (medical electrical safety) - referenced for safety considerations.
- ISO/TC 106 and CEN/TC 55 are the relevant technical committees responsible for the document.
This standard ensures intraoral cameras meet defined performance, safety and usability expectations, creating a common basis for product development, testing and clinical use.
