牙科 牙科修复材料、粘合材料、窝沟封闭剂和正畸粘合或粘合材料的抗菌活性评估

[中文适用范围]： 本文件规定了牙科修复材料、粘接材料、窝沟封闭剂和正畸粘接或粘接材料的评估测试方法，这些材料由各自的制造商声称具有“抗菌”效果。注意：本文件不涵盖牙髓封盖材料（例如氢氧化钙配方）、牙髓填充材料、牙科植入物或植入系统、夜间护齿器和增材制造（例如 3D 打印）材料。本文件不涵盖灭菌或消毒程序的有效性测试。本文件不能用于证明牙科使用的医疗器械没有微生物污染。 [外文原描述]： 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.