NF EN ISO 7197, S94-303 (11/2024)

ISO 7197:2006 specifies the safety and performance requirements for sterile, non-reusable hydrocephalus diversion systems and components, including valves, tubes and reservoirs. ISO 7197:2006 defines the mechanical and technical requirements for manufacturing. It defines the technical information concerning the valve which must be provided by the manufacturer. Taking into account that different types of valves operate according to different principles, specific characteristics are defined for each group according to the manufacturer's instructions. For the surgeon as for the patient, ISO 7197:2006 has the advantage of allowing a better understanding of the indications given by the manufacturer and of having standardized information concerning the operation of a product in good working order, equipped with new design features. For the manufacturer, the advantage is to define the important requirements applicable to the bypass systems which will be used as a basis for investigation in the development phases as well as for checks and tests during manufacturing.
(Automatic translation from French)