ISO 7197:2024

Neurosurgical implants — Sterile, single-use hydrocephalus shunts

Publication date:   Jul 31, 2024

General information

60.60 Standard published   Jul 31, 2024

ISO

ISO/TC 150 Implants for surgery

International Standard

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO 7197:2006

WITHDRAWN
ISO 7197:2006/Cor 1:2007

NOW

PUBLISHED
ISO 7197:2024
60.60 Standard published
Jul 31, 2024