Need help?

EN 12006-2:1998+A1:2009 Standard

wave
Save  

  Keywords:

#implants #cardiac #segments #cardio #system

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

  Purpose

This standard describes specific requirements for vascular prostheses, including cardiac valve conduits, of synthetic or biological origin intended to replace, to reconstruct, to bypass or to form shunts between segments of the cardio-vascular system in humans.

  Publication

Wednesday 25th of March 2020

  Amendment

This standard is an amendment for "EN 12006-2:1998"

  Related Standards

EN 1641:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Materials

EN 60601-2-47:2001

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-47: Particular requirements for the safety, including essential performance, of ambulatory e...

EN 60601-2-13:2006/A1:2007

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systemsI...

EN 60601-2-20:2009

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transpo...

EN 60601-2-25:1995

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographsIEC 60601-2-25:1993

EN 60601-2-25:1995/A1:1999

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographsIEC 60601-2-25:1993

  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 12006-2:1998+A1:2009 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