NA 027

DIN Standards Committee Optics and Precision Mechanics

Project

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

Abstract

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.

Begin

2021-09-15

WI

00285143

Planned document number

EN ISO 7197

Responsible national committee

NA 027-05-08 AA - Neurosurgical implants  

Responsible european committee

CEN/TC 285 - Non-active surgical implants  

draft standard

Neurosurgical implants - Sterile, single-use hydrocephalus shunts (ISO/FDIS 7197:2024)
2024-05
Order from DIN Media

previous edition(s)

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)
2009-05

Order from DIN Media

Contact

Klaus Zeier

Alexander-Wellendorff-Str. 2
75172 Pforzheim

Tel.: +49 7231 9188-15
Fax: +49 7231 9188-33

Send message to contact