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EVS-EN ISO 7197:2024

Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO 7197:2024)

General information

Valid from 16.12.2024
Base Documents
ISO 7197:2024; EN ISO 7197:2024
Directives or regulations
None

Standard history

Status
Date
Type
Name
16.12.2024
Main
03.12.2009
Main
This document specifies the 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 does not provide any recommendations on which type of valve is most suitable for any specific context of use.
This document specifies the mechanical and technical requirements to manufacture shunts and the technical information of the valve to be supplied by the manufacturer.
This document does not apply to active implants for the treatment of hydrocephalus.

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