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EVS-EN ISO 25539-2:2009

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

General information

Withdrawn from 04.01.2013
Base Documents
ISO 25539-2:2008; EN ISO 25539-2:2009
ICS Groups
11.040.40 Implants for surgery, prosthetics and orthotics
Directives or regulations
93/42/EEC Medical devices (MDD)

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 93/42/EEC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history

Status
Date
Type
Name
04.01.2013
Main
EVS-EN ISO 25539-2:2012
03.03.2011
Corrigendum
EVS-EN ISO 25539-2:2009/AC:2011
Main
EVS-EN ISO 25539-2:2009
Main
EVS-EN ISO 25539-2:2008
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.

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Standard monitoring
English (PDF 268 KB)

Related products

Main

EVS-EN ISO 25539-2:2012

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
Withdrawn from 15.10.2020
Corrigendum

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

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
Newest version Withdrawn from 04.01.2013
Main

EVS-EN ISO 14630:2012

Non-active surgical implants - General requirements (ISO 14630:2012)
Newest version Valid from 04.01.2013
Main

EVS-EN ISO 16061:2021

Instruments for use in association with non-active surgical implants - General requirements (ISO 16061:2021)
Newest version Valid from 15.04.2021

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English