牙科 根管封闭材料

[中文适用范围]： 本文件规定了牙科根管封闭材料的分类、要求和试验方法。本文件适用于常规顺向根管封闭（1型）材料和其他根管封闭程序（包括根尖诱导成形术、穿孔填充、吸收治疗或逆向根尖填充）（2型）的材料。2型根管封闭材料可用于活髓治疗。然而，本文件未涉及或包括对活髓治疗的要求。本文件未规定无菌性的要求或试验方法。注1：可参考适用的国家法规和国际公认的药典。注2：如有，可使用关于灭菌过程的国家要求。也有关于验证灭菌过程方法的标准：ISO 11737-1、ISO 11737-2和ISO 11737-3。 [外文原描述]： This document specifies the classification, requirements and test methods for endodontic sealing materials used in dentistry. This document is applicable to materials used for conventional orthograde endodontic sealing (Type 1) and materials used for other endodontic sealing procedures including apexification, perforation filling, resorption treatment or retrograde root-end filling (Type 2). The Type 2 endodontic sealing materials may be used for vital pulp therapy. However, this document does not address or include requirements for vital pulp therapy. This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations and internationally accepted pharmacopeias can be made. NOTE 2 National requirements regarding sterilization processes, if available, can be used. Standards on methods of validating sterilization processes are also available: ISO 11737-1, ISO 11737-2 and ISO 11737-3.