標準號：ISO 7197-2006
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
英文標準名稱：Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components
標準類型：C35
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C35
國際標準分類號：11.040.40
引用標準：ISO 10993-1;ISO 14630-2005;ASTM F 2503-2005
適用范圍：This International Standard 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.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 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 this International Standard 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.This International Standard does not apply to active implants for the treatment of hydrocephalus.