EN ISO 25539-1:2008

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 A1:2005)

1.1   Dieser Teil der ISO 25539 legt auf der Grundlage des derzeitigen medizinischen Wissenstandes Anfor¬derungen 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 endovas-kulären 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)

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: 14-Oct-2008
• Withdrawal Date: 05-May-2009
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285 - Non-active surgical implants
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 06-May-2009
• Completion Date: 06-May-2009
• 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 14299:2004 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Specific requirements for arterial stents
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 25539-1:2009 - Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
• Effective Date: 13-May-2009

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 25539-1:2009
01-januar-2009
1DGRPHãþD
SIST EN 14299:2004
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 A1:2005)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothèses
endovasculaires (ISO 25539-1:2003, Amd 1:2005 inclus)
Ta slovenski standard je istoveten z: EN ISO 25539-1:2008
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
October 2008
ICS 11.040.40 Supersedes EN 14299:2004
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 A1:2005)
This European Standard was approved by CEN on 9 September 2008.
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: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 25539-1:2008: E
worldwide for CEN national Members.

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SIST EN ISO 25539-1:2009
EN ISO 25539-1:2008 (E)
Contents Page
Foreword.3
Annex ZA (informative)  Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC.4

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SIST EN ISO 25539-1:2009
EN ISO 25539-1:2008 (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 25539-1:2008 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 April 2009, and conflicting national standards shall be withdrawn at the
latest by April 2009.
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 together with EN ISO 25539-2 supersedes EN 14299:2004.
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 EC Directive.
For relationship with EC 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
...