EN ISO 25539-2:2009

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

ISO 25539-2:2008 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.
The scope of ISO 25539-2:2008 includes vascular stents used to treat vascular lesions or stenoses, or other vascular abnormalities. These devices might or might not incorporate surface modifications of the stent such as drug and/or other coatings. Stents covered with materials that significantly modify the permeability of the uncovered stent are within the scope of ISO 25539-1:2003. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1:2003 and ISO 25539-2:2008.
Delivery systems are included in ISO 25539-2:2008 if they comprise an integral component of the deployment of the vascular stent.
Some pharmacological aspects of drug eluting stents are addressed in ISO 25539-2:2008, but this document is not comprehensive with respect to the pharmacological evaluation of drug eluting stents.
With the exception of sterilization, ISO 25539-2:2008 does not address requirements for the evaluation of animal tissue products.

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

1.1 Dieser Teil der ISO 25539 legt auf der Grundlage des derzeitigen medizinischen Wissensstandes
Anforderungen an Gefäßstents fest. Im Hinblick auf die Sicherheit enthält sie 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. Sie sollte als
Ergänzung zur ISO 14630 angesehen werden, die allgemeine Anforderungen an die Funktion nichtaktiver
chirurgischer Implantate festlegt.
ANMERKUNG Aufgrund der Variationen in der Konstruktion der von diesem Teil der ISO 25339 abgedeckten
Implantate sowie in einigen Fällen aufgrund der noch relativ neuen Entwicklung einiger dieser Implantate (z. B.
bioabsorbierbare Stents, Polymerstents) stehen nicht immer annehmbare genormte In-vitro-Prüfungen und klinische
Ergebnisse zur Verfügung. Mit dem Verfügbarwerden weiterer wissenschaftlicher und klinischer Daten wird eine
entsprechende Überarbeitung dieses Dokumentes erforderlich.
1.2 Der Anwendungsbereich dieses Teils von ISO 25539 schließt Gefäßstents ein, die zur Behandlung
vaskulärer Läsionen oder Stenosen oder sonstiger vaskulärer Anomalien eingesetzt werden. Bei diesen
Implantaten können Oberflächenmodifikationen des Stents, wie z. B. Medikamenten- und/oder weitere
Beschichtungen vorliegen. Stents, die mit Materialien ummantelt sind, die die Durchlässigkeit eines nicht
ummantelten Stents signifikant modifizieren, liegen im Anwendungsbereich der ISO 25539-1. Die Stentkonstruktion
kann die Anwendung funktionaler Anforderungen sowohl der ISO 25539-1 als auch dieses Teils
der ISO 25539 erforderlich machen.
1.3 Einführsysteme werden durch diesen Teil der ISO 25539 abgedeckt, sofern sie einen integralen
Bestandteil bei der Entfaltung des Gefäßstents darstellen.
1.4 Verfahren und Implantate, die vor der Einführung des Gefäßstents verwendet wurden, wie z. B. durch
Ballonangioplastie eingebrachte

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

L'ISO 25539-2:2008 spécifie les exigences relatives aux stents vasculaires selon les connaissances médicales actuelles. En ce qui concerne la sécurité, elle donne les exigences relatives aux performances attendues, aux caractéristiques de conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant. Il convient de la considérer 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 25539-2:2008 inclut les stents utilisés dans le traitement des lésions vasculaires ou sténoses, ou d'autres anomalies vasculaires. Ces dispositifs peuvent comprendre ou non, des modifications de surface du stent telles qu'un revêtement renfermant ou non un médicament. Les stents recouverts de matériaux qui modifient sensiblement l'étanchéité du stent nu sont compris dans le domaine d'application de l'ISO 25539-1:2003. La conception des stents peut rendre nécessaire d'analyser les exigences fonctionnelles identifiées à la fois dans l'ISO 25539-1:2003 et dans l'ISO 25539-2:2008.
Les systèmes d'injection sont inclus dans l'ISO 25539-2:2008 s'ils comprennent un composant intégral du déploiement du stent vasculaire.
Certains aspects pharmacologiques des stents à élution de médicaments sont traités dans l'ISO 25539-2:2008, mais celle-ci ne détaille pas l'évaluation pharmacologique de ce type de stent.
À l'exception de la stérilisation, l'ISO 25539-2:2008 ne traite pas les exigences relatives à l'évaluation des produits de tissus animaux.

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

General Information

• Status: Withdrawn
• Publication Date: 05-May-2009
• 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
• 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 25539-2:2009 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

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 25539-2:2008 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
• Effective Date: 13-May-2009
• Replaced By: EN ISO 25539-2:2012 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)
• Effective Date: 26-Dec-2012
• Corrected By: EN ISO 25539-2:2009/AC:2011 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 25539-2:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 25539-2:2008
9VDGNLLPSODQWDWL]DVUFHLQRåLOMH=QRWUDMåLOQLSULSRPRþNLGHOäLOQHRSRUQLFH
VWHQW,62
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-
2:2008)
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539
-2:2008)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Stents vasculaires
(ISO 25539-2:2008)
Ta slovenski standard je istoveten z: EN ISO 25539-2:2009
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 25539-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 25539-2:2009

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SIST EN ISO 25539-2:2009
EUROPEAN STANDARD
EN ISO 25539-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 25539-2:2008
English Version
Cardiovascular implants - Endovascular devices - Part 2:
Vascular stents (ISO 25539-2:2008)
Implants cardiovasculaires - Dispositifs endovasculaires - Kardiovaskuläre Implantate - Endovaskuläre Implantate -
Partie 2: Stents vasculaires (ISO 25539-2:2008) Teil 2: Gefäßstents (ISO 25539-2:2008)
This European Standard was approved by CEN on 20 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 25539-2:2009: E
worldwide for CEN national Members.

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SIST EN ISO 25539-2:2009
EN ISO 25539-2:2009 (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 25539-2:2009
EN ISO 25539-2:2009 (E)
Foreword
The text of ISO 25539-2:2008 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 25539-2:2009
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 25539-2:2008.
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, 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 the United K
...