scope:

This document specifies safety and performance requirements for sterile, single‑use non‑active hydrocephalus shunts. This includes not only the valve, but also additional components such as tubes and reservoirs.

This document gives no recommendation concerning the superiority of a certain type of valve.

For manufacturing, it specifies the mechanical and technical requirements. This document specifies the technical information supplied by the manufacturer, including the technical information of the valve. In respect to the principles of the different valve types, this document specifies characteristics for each type.

The benefit of this document 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 specify the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture.

This document does not apply to active implants for the treatment of hydrocephalus.