Abstract

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.

Begin

2021-09-30

WI

00285143

Planned document number

DIN EN ISO 7197

Project number

02703300

Responsible national committee

NA 027-05-08 AA - Neurosurgical implants  

Responsible european committee

CEN/TC 285 - Non-active surgical implants  

Responsible international committee

ISO/TC 150/WG 15 - Neurosurgical implants  

draft standard

Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO/DIS 7197:2023); German and English version prEN ISO 7197:2023
2023-07
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previous edition(s)

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007); German version EN ISO 7197:2009
2009-08

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