EN ISO 7197:2006

This International Standard specifies requirements for sterile, single-use hydrocephalus shunts and components. This International Standard is applicable to, but is not limited to: a) complete sterile, single-use hydrocephalus shunts of the one-piece type; or b) complete sterile, single-use hydrocephalus shunts of the multipiece type, supplied either assembled by the manufacturer or in kit form for assembly by the physician; or c) sterile, single-use shunt components which (individually or in combination) compromise shunt assemblies, for example: valves, valved catheters...