Final Draft International Standard
ISO/FDIS 7197
Neurosurgical implants — Sterile, single-use hydrocephalus shunts
Reference number
ISO/FDIS 7197
Edición 4
Final Draft
International Standard
ISO/FDIS 7197
83698
No disponible en español
Este borrador está en fase de aprobación.
Reemplazará ISO 7197:2006

Resumen

ISO 7197:2006 specifies safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components. This includes the components used in shunts, like valves, tubes and reservoirs.

For manufacturing, ISO 7197:2006 defines the mechanical and technical requirements. This International Standard defines the technical information of the valve, to be given by the manufacturer. In respect to the different principles of the valve types, specific characteristics are defined for each group as declared by the manufacturer.

The benefit of ISO 7197:2006 for the surgeon and the patient is to understand the information given by the manufacturer and to obtain standardized information about the performance of a well working product with new design characteristics. The benefit for the manufacturer is to define the important requirements for shunts as a basis for investigations during development as well as for quality control during manufacture.

Informaciones generales

  •  : En desarrollo
    : Envío de la prueba a la secretaría o inicio de la votación del FDIS: 8 semanas [50.20]
  •  : 4
     : 10
  • ISO/TC 150
    11.040.40 
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