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