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EN ISO 5840:2009 Standard

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  Keywords:

#heart #applicable #substitute #international #standard

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Cardiovascular implants - Cardiac valve prostheses (ISO 5840:2005)

  Purpose

1.1 This International Standard is applicable to all devices intended for implantation in human hearts, as a heart valve substitute. 1.2 This International Standard is applicable to both newly developed and modified heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 5840:2005"

Anyway is still possible use the "EN ISO 5840:2005" until March 21st, 2010

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