ISO/TC 106/WG 10 - Biological evaluation

This document specifies test methods for the evaluation of dental restorative materials, luting materials, fissure sealants and orthodontic bonding or luting materials that are claimed by their respective manufacturers to exert “antibacterial” effects. NOTE Materials for pulp capping (e.g. calcium hydroxide formulations), endodontic filling materials, dental implants or implant systems, nightguards and additive manufactured (e.g. 3D-printed) materials are not covered in this document. This document does not cover tests on the effectiveness of sterilization or disinfection procedures. This document cannot be used to demonstrate a lack of microbial contamination of medical devices used in dentistry.

ISO 7405:2008 specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. ISO 7405:2008 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.