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CEN

EN ISO 25539-1:2009/AC:2011

(Corrigendum)

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

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

2011-01-24 EMA: corrigendum in order to add that EN ISO 25539 Parts 1 supersede EN 12006-3 (following resolution 439 taken on 2011-01-10).

Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 1: Endovaskuläre Prothesen (ISO 25539-1:2003, einschließlich Amd 1:2005)

Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothèses endovasculaires (ISO 25539-1:2003, Amd 1:2005 inclus)

Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 1. del: Znotrajžilne proteze (ISO 25539-1:2003, vključno z Amd 1:2005)

1.1 Ta del ISO 25539 določa zahteve za znotrajžilne proteze, 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.
1.2 Ta del ISO 25539 velja za znotrajžilne proteze, uporabljene za zdravljenje arterijskih anevrizem, arterijskih stenoz ali drugih ustreznih žilnih nepravilnostih.
1.3 Ta del ISO 25539 velja za sisteme prenosa, če vsebujejo sestavni del postavitve znotrajžilnih protez.
1.4 Ta del ISO 25539 ne velja za žilne zapore, razen iliakalnih zapor v nasprotni smeri, kadar so uporabljene kot sestavni del aortnega uni-iliakalnega pripomočka. Glej ISO 14360 za izvzete proizvode.
1.5 Ta del ISO 25539 ne velja za postopke in pripomočke, uporabljene pred predstavitvijo znotrajžilnega sistema (določeno v točki 3.6), kot so znotrajžilne naprave z balonom.

General Information

Status
Withdrawn
Publication Date
15-Feb-2011
Withdrawal Date
14-Mar-2017
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
Completion Date
15-Mar-2017
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 25539-1:2009/AC:2011 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

Relations

Replaced By
EN ISO 25539-1:2017 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)
Effective Date
22-Mar-2017
Corrects
EN ISO 25539-1:2009 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
Effective Date
08-Jun-2022

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EN ISO 25539-1:2009/AC:2011EN ISO 25539-1:2009/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 1: Endovaskuläre Prothesen (ISO 25539-1:2003, einschließlich Amd 1:2005)Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothèses endovasculaires (ISO 25539-1:2003, Amd 1:2005 inclus)Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN ISO 25539-1:2009/AC:2011SIST EN ISO 25539-1:2009/AC:2011en,fr,de01-julij-2011SIST EN ISO 25539-1:2009/AC:2011SLOVENSKI
STANDARD



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



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN ISO 25539-1:2009/AC
February 2011
Février 2011
Februar 2011 ICS 11.040.40 English version Version Française Deutsche Fassung
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothèses endovasculaires (ISO 25539-1:2003, Amd 1:2005 inclus)
Kardiovaskuläre Implantate - Endovaskuläre Imp
...

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