本文件规定了有关固定牙科装置的要求和试验方法 a） 固定牙科装置与压缩空气供应、供水、抽吸供应和废水排放管道的连接特性， b） 固定牙科装置内压缩空气和水系统的材料、设计和施工， c） 进水和空气质量， d） 固定式牙科单元吸引系统的性能，以及 e） 固定牙科装置连接到牙科手机接口的空气、水、吸力和废水特性。 本文件还规定了使用说明和技术说明的要求。 本文件未规定固定牙科装置水线生物膜控制有效性的要求或测试方法。 注意ISO？中规定了固定牙科装置水线生物膜控制有效性的测试方法16954 本文件仅适用于不用于需要无菌空气和供水的口腔手术治疗的固定牙科装置。本文件不包括汞合金分离器。

This document specifies requirements and test methods for stationary dental units concerning a) the properties of stationary dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing, b) the materials, design, and construction of the compressed air and water system within the stationary dental unit, c) the quality for incoming water and air, d) the performance of stationary dental unit suction system, and e) the air, water, suction and wastewater properties of stationary dental unit connections to the interfaces to dental handpieces. This document also specifies requirements for instructions for use and technical description. This document does not specify requirements or test methods for the effectiveness of stationary dental unit waterline biofilm control. NOTE？Test methods for the effectiveness of stationary dental unit waterline biofilm control are specified in ISO？16954. This document is only applicable to stationary dental units that are not used for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in this document.