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
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
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.