標準號：DIN EN ISO 7197-2009
中文標準名稱：神經外科植入物.無菌、一次性使用的腦積水分流管和組件(ISO 7197-2006,包括技術勘誤 1-2007);德文版本 EN ISO 7197-2009
英文標準名稱：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
標準類型：C45
發布日期：1999/12/31 12:00:00
實施日期：2009/8/1 12:00:00
中國標準分類號：C45
國際標準分類號：11.040.40
引用標準：ISO 10993-1;ISO 14630-2005;ISO 14971;ASTM F640-1979
適用范圍：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.