Defines requirements for sterile, single-use hydrocephalus shunts and components. Applies to: complete sterile, single-use hydrocephalus shunts of one-piece type: complete sterile, single-use hydrocephalus shunts of multipiece type, either assembled by the manufacture or in kit form: or sterile, single-use shunt components which comprise shunt assemblies, eg valves, valved catheters (integral valves), inflow or outflow catheters (arterial, peritoneal, ventricular), connectors, implantable accessory devices eg siphoning-prevention, measuring and reservoirs/priming devices. Also for other applications.