BS EN ISO 7197:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements for shunts
5 Specific requirements for components
6 Marking and labeling for shunts
7 Packaging
8 Information supplied by the manufacturer
Bibliography
Annex ZA (informative) - Relationship between this European
                         Standard and the Essential Requirements
                         of EU Directive 93/42/EEC

Describes safety and performance requirements for sterile, single-use non-active hydrocephalus shunts and components.

This International Standard 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.

This International Standard gives no recommendation concerning the superiority of a certain type of valve.

For manufacturing, it 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 this International Standard 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.

This International Standard does not apply to active implants for the treatment of hydrocephalus.