Need help?

EN 12006-3:1998+A1:2009 Standard

wave
Save  

  Keywords:

#implants #design #evaluation #manufacturing #sterilization

  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 3: Endovascular devices

  Purpose

This European Standard specifies particular requirements for endovascular devices. With regard to safety, this standard gives in addition to EN ISO 14630, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

  Publication

Wednesday 25th of March 2020

  Amendment

This standard is an amendment for "EN 12006-3:1998"

  Related Standards

EN 14562:2006

Medical devices Directive (93/42/EEC)

Chemical disinfectants and antiseptics - Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for in...

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 60601-1-6:2010

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Us...

EN 60601-2-1:1998

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to ...

EN 60601-2-1:1998/A1:2002

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-1: Particular requirements for the safety of electron accelerators in the range of 1 MeV to ...

EN 60601-2-8:1997

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2: Particular requirements for the safety of therapeutic X-ray equipment operating in the rang...

  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 12006-3:1998+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