EN ISO 7197 Test for Neurosurgery Implants

Medical Tests

EN ISO 7197 Test for Neurosurgery Implants

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 7197 testing. This standard specifies safety and performance requirements for sterile, disposable inactive hydrocephalus shunts and their components.

EN ISO 7197 Test for Neurosurgery Implants

This includes components used in shunts such as valves, tubing, and reservoirs.

For manufacturing, ISO 7197 defines mechanical and technical requirements. This International Standard defines the technical information of the valve to be supplied by the manufacturer. Regarding the different principles of valve types, specific features are defined for each group as declared by the manufacturer.

The benefit of ISO 7197 for surgeon and patient is to understand the information provided by the manufacturer and to obtain standardized information about the performance of a well-functioning product with new design features. The benefit of the manufacturer is to define important requirements for shunts as a basis for research during development as well as for quality control during production.

EUROLAB assists manufacturers with EN ISO 7197 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.

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