YY/T 0487-2010 in English

本标准规定了一次性使用无菌脑积水分流器及其组件的安全性和性能要求。包括分流器所用的组件,如阀、管路和储液器。
本标准不给出哪种阀更优越的建议。
本标准为生产规定了机械和技术要求,并给出了制造商提供的阀的技术信息。制造商需根据各类阀的工作原理,给出各类阀的专用特性。
本标准带给医生和病人的好处在于,可根据本标准理解制造商所提供的信息,从而获取具有设计创新产品的有关正常使用性能的标准化的信息。本标准带给制造商的好处在于,使他们明确分流器在开发研究和生产质量控制中的基本的重要要求。
本标准不适用于治疗脑积水的有源植入器械。

Scope

This standard specifies the safety and performance requirements for single-use sterile hydrocephalus shunts and their components. Includes components used in the diverter, such as valves, tubing, and reservoirs. This standard does not give a recommendation as to which valve is superior. This standard specifies mechanical and technical requirements for production and gives technical information on valves provided by the manufacturer. Manufacturers need to give the special characteristics of various types of valves based on their working principles. The benefit of this standard to physicians and patients is that they can understand the information provided by the manufacturer based on this standard, thereby obtaining standardized information on the normal performance of innovative products for the design of innovative products. The benefit of this standard to manufacturers is that it enables them to clarify the basic important requirements for shunt development, research and production quality control. This standard does not apply to active implantable devices for the treatment of hydrocephalus.