ISO 7551:2023 牙科 牙髓吸收点

标准编号：ISO 7551:2023

中文名称：牙科 牙髓吸收点

英文名称：Dentistry — Endodontic absorbent points

发布日期：2023-05

标准范围

本文件规定了牙髓手术中使用的无菌吸收点的要求和测试方法。吸收点以灭菌或非灭菌的形式上市。这些要求适用于已经按照制造商批准的方式灭菌一次的吸收点。本文件规定了用于指定吸收点尺寸的数值系统和颜色编码系统。条款？7规定了所需的标签和包装，包括使用说明。制造商声称未开封包装的内容物是无菌的，这是制造商的责任（见表？2）.本文件未规定无菌要求或试验方法。注1可参考适用的国家法规。参考国际公认的药典。注2国家要求可能适用。还提供了关于灭菌工艺验证方法的标准:ISO 11137-1、ISO 11137-2和ISO 11137-3。

This document specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points.

Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility.

NOTE 1 Reference to applicable national regulations can be made.

Reference is made to internationally accepted pharmacopoeia.

NOTE 2 National requirements can apply.

Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.

标准预览图