This International Standard specifies requirements for torque transmissions used in oral implantology in conjunction with a dental handpiece as an accessory during the insertion of dental implants and the further handling of craniofacial connectors. This International Standard applies to torque transmissions used for insertion and removal in the patient's oral cavity and which are connected to electric drive systems with torque control, but it does not apply to the electric drive systems themselves. This International Standard does not cover the dental implant and parts, that can be connected to this. For safety, this International Standard specifies requirements for classification, intended performance, performance characteristics, material selection, performance evaluation, manufacturing, remanufacturing and information to be provided by the manufacturer.
EN ISO 17509:2016 Referenced Document
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
ISO 10664:2014 Hexalobular internal driving feature for bolts and screws
ISO 13504:2012 Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment
ISO 16443:2014 Dentistry - Vocabulary for dental implants systems and related procedure
ISO 1797-1:2011 Dentistry - Shanks for rotary instruments - Part 1: Shanks made of metals