It is currently not possible to order printed and bound versions of standards. This is due to challenges related to our printing supplier. We are working to resolve the situation and apologize for any inconvenience this may cause. For other options, contact salg@standard.no.
Standard

NS-EN ISO 7197:2009

Withdrawn

Note: This standard has a new edition: NS-EN ISO 7197:2024

Preview

Corrigenda and amendments are bought separately.

Language
Services

Abstract

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.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2009-05
  • Version: 1
  • Document type: NAT
  • ICS 11.040.40
  • National Committee CEN/TC 285

Legal references

EU law: 93/42/EEC, 2007/47/EC

Product Relations

Product life cycle