ISO/FDIS 7197
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Neurosurgical implants — Sterile, single-use hydrocephalus shunts
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
31-07-2024
English, French
29-04-2024
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.
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