DIN EN ISO 13504:2012-10

This standard contains requirements for the content of technical documentation prepared to verify the approval requirements for a dental implant and any pre-manufactured part of it which remains in the mouth after the dental procedure. Instruments and other parts manufactured especially for an implant system, but not remaining in the mouth, are outside the scope of this standard. The documentation on these components can still be included in the technical documentation. The International Standard has been prepared by ISO/TC 106/SC 4/WG 13 "Implant instruments" (secretariat: DIN) in collaboration with CEN/TC 55 "Dentistry" (secretariat: DIN). The responsible committee at DIN is NA 014-00-21-02 AK "Instrumente für die dentale Implantologie" ("Instruments for dental implantology") at NA 014-00-21 AA "Dentalimplantate" ("Dental implants") of NADENT.