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) comprise shunt assemblies, for example: valves, valved catheters (catheter with integral valves), inflow or outflow catheters (such as arterial, peritoneal, ventricular catheters), connectors, implantable accessory devices (such as siphoning-preventing devices, measuring devices and reservoirs/priming devices).