DIN 13978:2012-03

This standard applies to filling instruments with contra set with metallic working ends used for processing plastic filling materials. It specifies requirements and test methods for the shapes and dimensions of the working ends. Moreover, information about marking is specified. This standard has been prepared by Working Committee NA 014-00-23 AA "Dentalmedizinische Instrumente" ("Dental medical instruments") of the Dentistry Standards Committee (NADENT) at DIN, the German Institute for Standardization e. V. At dental practices filling instruments come into contact with patients in correspondence with the intended application. For this reason, they are subject to the German Medical Devices Act and are classified as Class 1 Medical Devices. An important point is therefore the requirements for reprocessing specified in correspondence with the Robert Koch Institute guideline (RKI-Richtlinie). Filling instruments shall display an ergonomically practical shape. Filling instruments with contra set are suitable to fulfil the ergonomic requirements of the basic requirements of the German Medical Devices Act.