Need help?

EN ISO 7197:2009 Standard

wave
Save  

  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

  Related Standards

EN 13795-1:2019

Medical devices Directive (93/42/EEC)

Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns

EN ISO 15883-3:2009

Medical devices Directive (93/42/EEC)

Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste contai...

EN ISO 17665-1:2006

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a...

EN ISO 17664:2004

Medical devices Directive (93/42/EEC)

Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical dev...

EN ISO 17510-2:2009

Medical devices Directive (93/42/EEC)

Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

EN ISO 17510-1:2009

Medical devices Directive (93/42/EEC)

Sleep apnoea breathing therapy - Part 1: Sleep apnoea breathing therapy equipment (ISO 17510-1:2007)

  Stay up to date

CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.

CELAB performs voluntary inspection activities on technical construction files to check their contents.

CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.

CLICK HERE TO GET TESTS AND INFO ON THE EN ISO 7197:2009 STANDARD

  ACCESS

Search for a standard
GO

Register

Already a member?
Login

  OTHER APPLICATIONS

If you are interested in DO160 tests, you can give a try to our other free of charge software:
CE-Marking assistant, Version: 1.3.0