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Standards Development
This document specifies requirements and test methods for reusable intra-oral mirrors with a coated glass reflecting surface used for dental purposes in the oral cavity.
In addition, specific requirements for metallic and polymeric casing and handles are given.
Intra-oral mirrors are hand-held dental instruments intended for use in patients’ oral cavities for intraoral inspection and tissue retraction. During clinical use, these instruments are exposed to mechanical handling, repeated cleaning, disinfection, and sterilization processes. The optical performance of the reflecting surface, including magnification and distortion, as well as the mechanical integrity and corrosion resistance of the materials, are essential to ensure reliable clinical performance and patient safety.
This document specifies requirements and test methods for intra-oral mirrors, including design, dimensions, materials, optical properties, and resistance to reprocessing, in order to support appropriate product design and material selection, ensure consistent optical and mechanical performance, and facilitate harmonized regulatory and manufacturing practices
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