UNE-EN ISO 7197:2025

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.