Need help?

EN ISO 5840:2009 Standard

wave
Save  

  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

  Related Standards

EN 60601-2-29:2008

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy s...

EN ISO 23328-1:2008

Medical devices Directive (93/42/EEC)

Breathing system filters for anaesthetic and respiratory use - Part 1: Salt test method to assess filtration performance (ISO 2332...

EN 27740:1992/AC:1996

Medical devices Directive (93/42/EEC)

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

EN 27740:1992/A1:1997

Medical devices Directive (93/42/EEC)

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

EN 27740:1992

Medical devices Directive (93/42/EEC)

Instruments for surgery, scalpels with detachable blades, fitting dimensions (ISO 7740:1985)

EN ISO 26782:2009/AC:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 267...

  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 5840:2009 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