Need help?

EN ISO 25539-1:2009/AC:2011 Standard

wave
Save  

  Keywords:

#requirements #design #endovascular #performance #specifies

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

  Purpose

This part of ISO 25539 specifies requirements for endovascular prostheses, based upon current medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization packaging and information supplied by the manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

  Publication

Friday 17th of November 2017

  Correction

This standard is a correction for "EN ISO 25539-1:2009"

  Related Standards

EN 60601-2-33:2010/A12:2016

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic reson...

EN ISO 14889:2009

Medical devices Directive (93/42/EEC)

Ophthalmic optics - Spectacle lenses - Fundamental requirements for uncut finished lenses (ISO 14889:2003)

EN ISO 15223-1:2016

Medical devices Directive (93/42/EEC)

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requir...

EN ISO 15004-1:2009

Medical devices Directive (93/42/EEC)

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic ins...

EN ISO 15001:2011

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Compatibility with oxygen (ISO 15001:2010)

EN ISO 14971:2012

Medical devices Directive (93/42/EEC)

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

  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 25539-1:2009/AC:2011 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