牙科-手机扭矩变送器(ISO 17509:2016)

[中文适用范围]： 本国际标准规定了在插入牙种植体和进一步操作颅面连接器时，口腔种植术中与牙科手机作为附件一起使用的扭矩传输的要求。 本国际标准适用于用于在患者口腔中插入和取出并连接到具有扭矩控制的电力驱动系统的扭矩传输装置，但不适用于电力驱动系统本身。 本国际标准不包括牙科种植体和零件可以连接到这个。 为了安全起见，本国际标准规定了分类、预期性能、性能特征、材料选择、性能评估、制造、再制造以及制造商应提供的信息的要求。 [外文原描述]： ISO 17509:2016 specifies requirements for torque transmitters to be used in oral implantology in conjunction with a dental handpiece as an accessory in the placement of dental implants and the further manipulation of connecting parts in the craniofacial area. ISO 17509:2016 applies to torque transmitters used for placement and for removal in the oral cavity of the patient which are connected to power-driven systems having torque control mechanism, but does not apply to the power-driven systems themselves. ISO 17509:2016 does not include the dental implant nor parts that would be connected to it. With regard to safety, this International Standard gives requirements for classification, intended performance, performance attributes, material selection, performance evaluation, manufacture, reprocessing and information to be supplied by the manufacturer.