牙科学.整合牙线和牙线柄

[中文适用范围]： 本文件规定了用于家庭护理、社区护理、口腔健康专业护理或牙科治疗一部分的一体式牙线和手柄的要求和测试方法。 本文件适用于手动使用的集成牙线和手柄。 它不包括牙线和含有连续供应的牙线的手柄，或者随后添加牙线的手柄。 本文件不包括用于证明不存在不可接受的生物风险的特定定性和定量测试方法。 有关此类生物风险的评估，请参阅 ISO 10993-1 和 ISO 7405。 [外文原描述]： This document specifies the requirements and test methods for integrated dental floss and handles used for home care, community care, professional care of oral health or a part of dental treatment. This document is applicable to integrated dental floss and handles for manual use. It does not include dental floss and handles which contain a continuous supply of dental floss, or handles to which the floss is subsequently added. This document excludes specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological risks. For assessment of such biological risks, see ISO 10993-1 and ISO 7405.