DIN Standards Committee Health Technologies
DIN EN ISO 13504
Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment (ISO 13504:2012); German version EN ISO 13504:2012
Zahnheilkunde - Allgemeine Anforderungen an bei der Implantation verwendete Instrumente und Zubehör (ISO 13504:2012); Deutsche Fassung EN ISO 13504:2012
Overview
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.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 014-00-21-02 AK - Instruments for dental implantology
