EN ISO 25539-1:2009

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

ISO 25539-1:2003 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.
ISO 25539-1:2003 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.
ISO 25539-1:2003 is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.
ISO 25539-1:2003 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.
ISO 25539-1:2003 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.

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

1.1 Dieser Teil der ISO 25539 legt auf der Grundlage des derzeitigen medizinischen Wissenstandes Anforderungen
an endovaskuläre Prothesen fest. Im Hinblick auf die Sicherheit enthält er Anforderungen an die
beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe/Materialien, die Bewertung der Konstruktion, die
Herstellung, die sterile Verpackung sowie die Bereitstellung von Informationen durch den Hersteller. Er sollte
als Ergänzung zur ISO 14630 angesehen werden, die allgemeine Anforderungen an die Funktion nichtaktiver
chirurgischer Implantate festlegt.
1.2 Dieser Teil der ISO 25539 gilt für endovaskuläre Prothesen zur Behandlung arterieller Aneurysmen,
arterieller Stenosen oder sonstiger entsprechender vaskulärer Anomalien.
1.3 Dieser Teil der ISO 25539 gilt für Einführsysteme, sofern diese einen integralen Bestandteil bei der
Entfaltung der endovaskulären Prothese darstellen.
1.4 Dieser Teil der ISO 25539 gilt nicht für Gefäß-Okkluder, mit Ausnahme von kontralateralen iliakalen
Okkludern, sofern diese als integraler Bestandteil eines aorto-uni-iliakalen Implantats verwendet werden.
Siehe ISO 14630 zu den ausgenommenen Produkten.
1.5 Dieser Teil der ISO 25539 gilt nicht für Verfahren und Implantate, die vor der Einführung des endovaskulären
Systems (definiert unter 3.6) verwendet wurden, wie z. B. durch Ballonangioplastie eingebrachte
Implantate.

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

L'ISO 25539-1 spécifie les exigences relatives aux prothèses endovasculaires, définies sur la base des connaissances médicales actuelles. En matière de sécurité, elle définit des exigences relatives aux performances prévues, aux caractéristiques de conception, aux matériaux, à l'évaluation de la conception, à la fabrication, la stérilisation, l'emballage et les informations fournies par le fabricant. Il convient de considérer cette norme comme un complément à l'ISO 14630, qui spécifie les exigences générales relatives aux performances des implants chirurgicaux non actifs.
Le domaine d'application de l'ISO 25539-1 inclut les prothèses endovasculaires utilisées dans le traitement des anévrysmes artériels, des sténoses artérielles ou d'autres anomalies vasculaires.
Les systèmes de largage sont inclus dans l'ISO 25539-1 s'ils font partie intégrante du système de mise en place des prothèses endovasculaires.
Les dispositifs d'occlusion vasculaire ne sont pas abordés dans l'ISO 25539-1, sauf lorsqu'il s'agit de dispositifs d'occlusion iliaque contralatérale utilisés comme partie intégrante d'un dispositif aorto-uni-iliaque. Voir l'ISO 14630 pour les produits exclus.
Les techniques et les dispositifs utilisés avant l'introduction du système endovasculaire, tels que les dispositifs d'angioplastie transluminale percutanée, sont exclus du domaine d'application de l'ISO 25539-1.

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

General Information

• Status: Withdrawn
• Publication Date: 05-May-2009
• 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
• 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: SIST EN ISO 25539-1:2009 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)

Relations

• Replaces: EN 12006-3:1998+A1:2009 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
• Effective Date: 08-Jun-2022
• Replaces: EN ISO 25539-1:2008 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
• Effective Date: 13-May-2009
• Replaced By: EN ISO 25539-1:2017 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017)
• Effective Date: 09-Jul-2014
• Corrected By: EN ISO 25539-1:2009/AC:2011 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 25539-1:2009
01-julij-2009
1DGRPHãþD
SIST EN 12006-3:2000+A1:2009
SIST EN ISO 25539-1:2009
9VDGNLLPSODQWDWL]DVUFHLQRåLOMH=QRWUDMåLOQLSULSRPRþNLGHO=QRWUDMåLOQH
SURWH]H,62YNOMXþQR]$PG
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO
25539-1:2003 including Amd 1:2005)
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)
Ta slovenski standard je istoveten z: EN ISO 25539-1:2009
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 25539-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 25539-1:2009

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SIST EN ISO 25539-1:2009
EUROPEAN STANDARD
EN ISO 25539-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 25539-1:2008
English Version
Cardiovascular implants - Endovascular devices - Part 1:
Endovascular prostheses (ISO 25539-1:2003 including Amd
1:2005)
Implants cardiovasculaires - Dispositifs endovasculaires - Kardiovaskuläre Implantate - Endovaskuläre Implantate -
Partie 1: Prothèses endovasculaires (ISO 25539-1:2003, Teil 1: Endovaskuläre Prothesen (ISO 25539-1:2003,
Amd 1:2005 inclus) einschließlich Amd 1:2005)
This European Standard was approved by CEN on 19 April 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 25539-1:2009: E
worldwide for CEN national Members.

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SIST EN ISO 25539-1:2009
EN ISO 25539-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 25539-1:2009
EN ISO 25539-1:2009 (E)
Foreword
The text of ISO 25539-1:2003, including Amd 1:2005 has been prepared by Technical Committee ISO/TC 150
“Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 25539-1:2009 by Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of
which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 25539-1:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, C
...