ISO 7197:2006 神经外科植入材料,无菌的、一次性使用的脑积水分流管和组件

标准编号：ISO 7197:2006

中文名称：神经外科植入材料,无菌的、一次性使用的脑积水分流管和组件

英文名称：Neurosurgical implants — Sterile, single-use hydrocephalus shunts and components

发布日期：2006-06

标准范围

ISO 7197:2006规定了无菌一次性非活动性脑积水分流器和组件的安全和性能要求。这包括分流器中使用的部件，如阀门、管道和储罐。对于制造，ISO 7197:2006定义了机械和技术要求。本国际标准规定了制造商提供的阀门技术信息。关于阀门类型的不同原理，制造商为每组定义了特定特性。ISO 7197:2006对外科医生和患者的好处是了解制造商提供的信息，并获得关于具有新设计特征的良好工作产品性能的标准化信息。制造商的好处是定义分流器的重要要求，作为开发期间调查以及制造期间质量控制的基础。

ISO 7197:2006 specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs.For manufacturing, ISO 7197:2006 defines the mechanical and technical requirements. This International Standard defines the technical information of the valve, to be given by the manufacturer. In respect to the different principles of the valve types, specific characteristics are defined for each group as declared by the manufacturer.The benefit of ISO 7197:2006 for the surgeon and the patient is to understand the information given by the manufacturer and to obtain standardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to define the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture.

标准预览图