标准摘要
[中文适用范围]： 本文件规定了各种根管充填材料的尺寸要求，以及聚合物点、聚合物包覆的热塑性充填载体、非点状热塑性充填材料或上述材料组合用于根管系统充填时的射线不透性要求。文件还规定了预成根管充填点的尺寸标定的数值和颜色编码系统，用于确定注射材料熔融质量流动速率的方法，以及关于标识、标签、包装和使用说明的要求。牙科根管充填点以灭菌或非灭菌形式销售。灭菌不在本文件范围内。任何声称产品已灭菌的声明均由制造商负责（见表3）。本文件不适用于与热塑性充填材料一起使用的仪器或设备，也不适用于支持冠部修复的材料。第7条说明了标识、标签和包装，包括使用说明。本文件未规定灭菌的要求或测试方法。可参考适用的国家法规、国际公认药典以及用于验证灭菌过程的标准。 [外文原描述]： This document specifies the requirements for the dimensions of various endodontic obturating materials and the radiopacity for polymeric points, polymeric-coated thermoplastic obturating carriers, non-point-shaped thermoplastic obturating material, or combinations of the above used for obturation of a root canal system. It also specifies numerical and colour-coding systems for designating the sizes of preformed endodontic obturating points, a method for determining the melt mass-flow rate for injection material, and the requirements for marking, labelling, packaging and the instructions for use. Dental endodontic obturating points are marketed as sterilized or non-sterilized. Sterility is not included in this document. Any claim that the product is sterile is the manufacturer's responsibility (see Table 3). This document does not apply to instruments or apparatus used with obturating materials that become plastic with heat or materials supporting a coronal restoration. Clause 7 specifies marking, labelling and packaging, including the instructions for use. This document does not specify requirements or test methods for sterility. Reference to applicable national regulations, internationally accepted pharmacopoeia and standards for validating sterilization processes can apply.
英文名称Dentistry — Endodontic obturating materials