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现行 ISO 6877:2021
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Dentistry — Endodontic obturating materials 牙科学.牙髓充填材料
发布日期: 2021-09-08
本文件规定了各种根管充填材料的尺寸规范,包括适用于根管系统充填的预制金属、预制聚合物涂层金属、聚合物点、热塑性充填材料或上述材料的组合。本文件还规定了用于指定预制牙髓充填点尺寸的数字系统和颜色编码系统。 牙科牙髓充填点在市场上销售的是消毒或非消毒的。本文件涵盖了所提供产品的预期物理属性。 本文件不包括无菌,任何产品无菌的声明均由制造商负责(见表3)。 第7条规定了所需的标签,包括使用说明。 本文件不适用于与热塑性封闭材料(受热变形的封闭材料)一起使用的仪器或装置。本文件不适用于支持冠状修复的材料。
This document establishes the specifications for the dimensions of various endodontic obturating materials including preformed metal, preformed polymeric-coated metal, polymeric points, thermoplastic obturating material or combinations of the above, suitable for use in the obturation of the root canal system. This document also specifies numerical systems and a colour-coding system for designating the sizes of preformed endodontic obturating points. Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers the physical attributes expected of such products as supplied. Sterility is not included in this document, and any claim that the product is sterile is the responsibility of the manufacturer (see Table?3). Clause?7 specifies the labelling needed, including the instructions for use. This document does not apply to instruments or apparatus used in conjunction with thermoplastic obturating materials (obturating material that deform with heat). This document is not applicable to materials for support of a coronal restoration.
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归口单位: ISO/TC 106/SC 1
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