ISO/DIS 13504.2:2025

This document specifies general requirements for the manufacture of instruments and related accessories used in the placement of dental implants. It is applicable to single-use and reusable instruments, regardless of whether they are manually driven or connected to a power-driven system. This document does not apply to devices used for indirect contact with the human body, including the power-driven system itself, nor to the dental implant or to parts intended to be connected to the dental implant. With regard to safety, this document gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, sterilization and information to be supplied by the manufacturer.