标准摘要
[中文适用范围]： 本文件规定了无菌、一次性非主动脑积水分流器的性能要求。这不仅包括阀门，还包括管道和储液器等附加组件。本文件不提供任何关于哪种类型的阀门最适合任何特定使用环境的建议。本文件规定了制造分流器的机械和技术要求以及制造商应提供的阀门技术信息。本文件不适用于用于治疗脑积水的主动植入物。 [外文原描述]： This document specifies the performance requirements for sterile, single-use non-active hydrocephalus shunts. This includes not only the valve, but also additional components such as tubes and reservoirs. This document does not provide any recommendations on which type of valve is most suitable for any specific context of use. This document specifies the mechanical and technical requirements to manufacture shunts and the technical information of the valve to be supplied by the manufacturer. This document does not apply to active implants for the treatment of hydrocephalus.
英文名称Neurosurgical implants — Sterile, single-use hydrocephalus shunts