本文件规定了根管治疗过程中使用的无菌吸收点的要求和测试方法。吸附点在市场上是经过灭菌或未经灭菌的。这些要求适用于以制造商批准的方式消毒过一次的吸收点。本文件规定了用于指定吸收点尺寸的数字系统和颜色编码系统。 第7条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检测方法。 注1可以参考适用的国家法规。 参考了国际公认的药典。 注2:可适用国家要求。 还提供了验证灭菌过程方法的标准: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.