ONORM EN ISO 10451:2026

Dentistry - Contents of a technical file for dental implant systems (ISO 10451:2026)

This document specifies requirements for the contents of a Technical Documentation that is prepared to demonstrate compliance with the approval requirements for an endosseous dental implant, which may include:— implant body;— implant abutment;— abutment screw;— implant connector;— implant connector screw;— fastening screw;— implant closure screw;— transmucosal healing component.This document also specifies requirements for intended use and probation, design characteristics, components, biocompatibility, manufacturing, packaging, sterilization, shelf life, marking, labeling and the information provided by the manufacturer. This document does not apply to the following products:— dental implants containing animal or human components or bioactive properties;— custom-made products without prefabricated connections;— implantable materials for filling bone defects and augmentation in oral and maxillofacial procedures;— membrane materials for guided tissue regeneration in oral and maxillofacial procedures;— specific instruments intended for use as part of a dental implant system. NOTE 1 ISO 22794 specifies the required content of the technical documentation for implantable materials for bone defect filling and augmentation in oral and maxillofacial procedures. ISO 22803 specifies the required content of the technical documentation for membrane materials for guided tissue regeneration in oral and maxillofacial procedures. NOTE 2 ISO 13504 describes the general requirements for specific instruments intended for use as part of a dental implant system. These instruments require separate technical documentation.NOTE 3 Custom-made products are defined in IMDRF/PMD WG/N49 [5].