prBAS EN ISO 7197:2026
Neurosurgical implants - Sterile, single-use hydrocephalus shunts
General information
Status:Project
Number of pages:13
Adoption method:Proglašavanje
Language:engleski
Edition:3.
Realization date:28.11.2025
Forseen date for next stage code:20.02.2026
Technical committee:BAS/TC 25, Healthcare
ICS:
11.040.40, Implants for surgery, prosthetics and orthotics
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.
Lifecycle
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Original document and degree of correspondence
EN ISO 7197:2024, identical
ISO 7197:2024, identical
Relation to BAS standards
Work material
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