DIN EN ISO 7197-2009 神经外科植入物.无菌、一次性使用的脑积水分流管和组件(ISO 7197-2006,包括技术勘误 1-2007);德文版本 EN ISO 7197-2009

标准号：DIN EN ISO 7197-2009
中文标准名称：神经外科植入物.无菌、一次性使用的脑积水分流管和组件(ISO 7197-2006,包括技术勘误 1-2007);德文版本 EN ISO 7197-2009
英文标准名称：Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007); English version of DIN EN ISO 7197:2009-08
标准类型：C45
发布日期：1999/12/31 12:00:00
实施日期：2009/8/1 12:00:00
中国标准分类号：C45
国际标准分类号：11.040.40
引用标准：ISO 10993-1;ISO 14630-2005;ISO 14971;ASTM F640-1979
适用范围：This International Standard specifies safety and performance requirements for sterile, single-use non-activehydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes andreservoirs.This International Standard gives no recommendation concerning the superiority of a certain type of valve.For manufacturing, it defines the mechanical and technical requirements. This International Standard definesthe technical information of the valve, to be given by the manufacturer. In respect to the different principles ofthe valve types, specific characteristics are defined for each group as declared by the manufacturer.The benefit of this International Standard for the surgeon and the patient is to understand the informationgiven by the manufacturer and to obtain standardized information about the performance of a well workingproduct with new design characteristics. The benefit for the manufacturer is to define the importantrequirements for shunts as a basis for investigations during development as well as for quality control duringmanufacture.This International Standard does not apply to active implants for the treatment of hydrocephalus.