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CEN

EN ISO 25539-2:2009/AC:2011

(Corrigendum)

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

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

2011-01-24 EMA: corrigendum in order to add that EN ISO 25539 Parts 2 supersede EN 12006-3 (following resolution 439 taken on 2011-01-10).

Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2008)

Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Stents vasculaires (ISO 25539-2:2008)

Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 2. del: Žilne opornice (stent) (ISO 25539-2:2008)

Ta del ISO 25539 določa zahteve za žilne opornice (stent), zasnovane na sodobnem medicinskem znanju. Z upoštevanjem varnosti podaja zahteve za predvideno delovanje, lastnosti modela, materiale, ovrednotenje zasnove, izdelavo, sterilizacijo, pakiranje in informacije, ki jih priskrbi proizvajalec. Upoštevati se mora kot dodatek ISO 14630, ki določa splošne zahteve za delovanje neaktivnih kirurških implantatov.

General Information

Status
Withdrawn
Publication Date
15-Feb-2011
Withdrawal Date
30-Nov-2012
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
CEN/TC 285 - Non-active surgical implants
Drafting Committee
CEN/TC 285/WG 3 - Cardiac and vascular implants
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
01-Dec-2012
Completion Date
01-Dec-2012
Directive
2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 25539-2:2009/AC:2011 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

Relations

Replaced By
EN ISO 25539-2:2012 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
Effective Date
26-Dec-2012
Corrects
EN ISO 25539-2:2009 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
Effective Date
08-Jun-2022

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EN ISO 25539-2:2009/AC:2011EN ISO 25539-2:2009/AC:2011
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EN ISO 25539-2:2009/AC:2011
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Standards Content (Sample)


2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2008)Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Stents vasculaires (ISO 25539-2:2008)Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN ISO 25539-2:2009/AC:2011SIST EN ISO 25539-2:2009/AC:2011en,fr,de01-julij-2011SIST EN ISO 25539-2:2009/AC:2011SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 25539-2:2009/AC
February 2011
Février 2011
Februar 2011 ICS 11.040.40 English version Version Française Deutsche Fassung
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Stents vasculaires (ISO 25539-2:2008)
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2008) This c
...

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