ISO 7197-2006 神经外科植入物.无菌、一次性使用的脑积水分流管和组件

标准号：ISO 7197-2006
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
英文标准名称：Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components
标准类型：C35
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C35
国际标准分类号：11.040.40
引用标准：ISO 10993-1;ISO 14630-2005;ASTM F 2503-2005
适用范围：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.