What is ISO 23450 about?
ISO 23450 addresses Intraoral cameras in dentistry and specifies requirements and test methods for intraoral cameras used in dentistry on patients for pictorial representation of oral cavities to support diagnosis and facilitate patient information. It specifies requirements, test methods, instructions for use, and marking.
ISO 23450 does not apply to, powered polymerization activators for polymerization of dental materials, exclusively extraoral camera equipment to prepare overviews or to record treatments, dental microscopes for minimally invasive treatments, medical endoscopes, camera handpieces for tooth illumination (transillumination), CAD or CAM scanner handpieces, combinations of dental instruments with camera functions, cameras for endodontic purposes, devices for root canal inspection (endoscopic micro cameras), cameras for tool navigation, cameras for determination of tooth colour.
Who is ISO 23450 for?
ISO 23450 is useful for:
- Dentists
- Manufacturers of Intraoral cameras for dental purposes
- Manufacturers of medical devices
Why should you use ISO 23450?
An intraoral camera is an optical handpiece for use in the oral cavity of the patient to assist with diagnosis and facilitate patient information and treatment.
By using ISO 23450 guidelines you can manufacture an intraoral camera that will be designed and manufactured in a way so that its application jeopardizes neither the clinical condition and safety of the patient nor the health and safety of the operator or any third party. To maintain this high level of quality, ISO 23450 describes the applicable technical product features.