Need help?

EN ISO 25539-2:2009/AC:2011 Standard

wave
Save  

  Keywords:

#requirements #performance #design #specifies #considered

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

  Purpose

This part of ISO 25539 specifies requirements for vascular stents, 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 25539-2:2009"

  Related Standards

EN IEC 60601-2-66:2020

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids a...

EN ISO 7376:2009

Medical devices Directive (93/42/EEC)

Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation (ISO 7376:2009)

EN ISO 25424:2019

Medical devices Directive (93/42/EEC)

Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and rout...

EN 1707:1996

Medical devices Directive (93/42/EEC)

Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings

EN 1865-3:2012

Medical devices Directive (93/42/EEC)

Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher

EN 1865-4:2012

Medical devices Directive (93/42/EEC)

Patient handling equipment used in road ambulances - Part 4: Foldable patient transfer chair

  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 25539-2:2009/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