SRPS EN ISO 7197:2011

Neurosurgical implants - Sterile, single-use hydrocephalus shunts and components (ISO 7197:2006, including Cor 1:2007)

Scope

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.

Related directives

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.