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EN ISO 7197:2009 Standard

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  Keywords:

#international #valve #standard #defines #requirements

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

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.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 7197:2006"

Anyway is still possible use the "EN ISO 7197:2006" until March 21st, 2010

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