ISO 7197:2024
Neurosurgical implants — Sterile, single-use hydrocephalus shunts
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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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for shunts
4.1 General
4.2 Radiopacity
4.3 Biocompatibility
4.4 Resistance to leakage
4.5 Control of the implanted shunt
4.6 Pressure-flow characteristics of the valve, the components and the pre-assembled shunt
4.7 Identification of shunts in vivo
4.8 Ability to withstand overpressure
4.9 Dynamic breaking strength
4.10 Behaviour under magnetic resonance imaging conditions
4.11 Bursting pressure
5 Specific requirements for components
5.1 Valves
5.1.1 Reflux performance of shunts connecting the ventricle to the blood system
5.1.2 Long-term stability
5.1.3 Influence of the changed posture of the patient on the valve performance
5.2 Resistance of tubing and components
6 Marking and labelling of shunts
7 Packaging
8 Information supplied by the manufacturer
8.1 General
8.2 Instructions for use
8.3 Implant card
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for shunts
4.1 General
4.2 Radiopacity
4.3 Biocompatibility
4.4 Resistance to leakage
4.5 Control of the implanted shunt
4.6 Pressure-flow characteristics of the valve, the components and the pre-assembled shunt
4.7 Identification of shunts in vivo
4.8 Ability to withstand overpressure
4.9 Dynamic breaking strength
4.10 Behaviour under magnetic resonance imaging conditions
4.11 Bursting pressure
5 Specific requirements for components
5.1 Valves
5.1.1 Reflux performance of shunts connecting the ventricle to the blood system
5.1.2 Long-term stability
5.1.3 Influence of the changed posture of the patient on the valve performance
5.2 Resistance of tubing and components
6 Marking and labelling of shunts
7 Packaging
8 Information supplied by the manufacturer
8.1 General
8.2 Instructions for use
8.3 Implant card
Bibliography