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

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

1.1 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.
1.2 This part of ISO 25539 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.
1.3 This part of ISO 25539 is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.
1.4 This part of ISO 25539 is not applicable to vascular occluders, with the exception of contra-lateral iliac occluders when used as an integral part of an aorto-uni-iliac device. See ISO 14630 for excluded products.
1.5 This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of the endovascular system (defined in 3.6), such as balloon angioplasty devices.

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: 16-Jun-2011
• Withdrawal Date: 06-Apr-2017
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 07-Apr-2017
• Due Date: 30-Apr-2017
• Completion Date: 07-Apr-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
• Directive: 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: EN ISO 25539-1:2009/AC:2011 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

Relations

• Corrects: SIST EN ISO 25539-1:2009 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
• Effective Date: 01-Jul-2011
• Replaced By: SIST EN ISO 25539-1:2017 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)
• Effective Date: 01-May-2017
• Corrects: SIST 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

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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