EN ISO 25539-2:2008

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

2007-12-21 - Will supersede EN 14299 together with EN ISO 25539-2

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 Anfor¬de¬rungen an Gefäßstents fest. Im Hinblick auf die Sicherheit enthält sie Anforderungen an die beabsich¬tigte Funktion, Konstruktionsmerkmale, Werkstoffe/Materialien, die Bewertung der Konstruktion, die Her¬stellung, 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 vasku¬lärer Läsionen oder Stenosen oder sonstiger vaskulärer Anomalien eingesetzt werden. Bei diesen Implantaten können Oberflächenmodifikationen des Stents, wie z. B. Medikamenten  und/oder weitere Beschich¬tungen vorliegen. Stents, die mit Materialien ummantelt sind, die die Durchlässigkeit eines nicht ummantelten Stents signifikant modifizieren, liegen im Anwendungsbereich der ISO 25539 1. Die Stent-konstruktion 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.

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

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

General Information

• Status: Withdrawn
• Publication Date: 31-Aug-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 25539-2:2008 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)

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 25539-2:2009 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
• Effective Date: 13-May-2009

Standards Content (Sample)

SLOVENSKI STANDARD
01-november-2008
1DGRPHãþD
SIST EN 14299:2004
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: Endoprothèses
vasculaires (ISO 25539-2:2008)
Ta slovenski standard je istoveten z: EN ISO 25539-2:2008
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 25539-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2008
ICS 11.040.40 Supersedes EN 14299:2004
English Version
Cardiovascular implants - Endovascular devices - Part 2:
Vascular stents (ISO 25539-2:2008)
Implants cardiovasculaires - Dispositifs endovasculaires - Kardiovaskuläre Implantate - Endovaskuläre Implantate -
Partie 2: Endoprothèses vasculaires (ISO 25539-2:2008) Teil 2: Gefäßstents (ISO 25539-2:2008)
This European Standard was approved by CEN on 30 August 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 25539-2:2008: E
worldwide for CEN national Members.

Contents Page
Foreword.3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC.4

Foreword
This document (EN ISO 25539-2:2008) has been prepared by Technical Committee ISO/TC 150 "Implants for
surgery" in collaboration with 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 March 2009, and conflicting national standards shall be withdrawn at
the latest by March 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 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(s).
For relationship with EC Directive(s), 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 Kingdom.
Endorsement notice
The text of ISO 25539-2:2008 has been approved by CEN as a EN ISO 25539-2:2008 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) Essential Requirements (ERs) of Directive Qualifying
of this International 93/42/EEC remarks/Notes
Standard
4 1, 2, 4, 7.1
5 1, 2, 3, 4, 5, 7.1, 7.2, 7.3, 7.5, 8, 9.2

6 1, 2, 7.1, 7.2, 7.3, 7.5, 8.2, 9.2

7 1, 2, 3, 4, 6, 7.1, 7.2, 8, 9.2, 14

8 1, 2, 3, 5, 7.1, 7.2
9 1, 2, 3, 7.2, 8.1, 8.3, 8.4
10 1, 2, 3, 5, 7.2, 8.3, 8.4
11 1, 2, 8.7, 13.1, 13.3, 13.4, 13.6

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 25539-2
First edition
2008-09-01
Cardiovascular implants — Endovascular
devices —
Part 2:
Vascular stents
Implants cardiovasculaires — Dispositifs endovasculaires —
Partie 2: Endoprothèses vasculaires

Reference number
ISO 25539-2:2008(E)
©
ISO 2008
ISO 25539-2:2008(E)
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ISO 25539-2:2008(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements. 4
4.1 Classification. 4
4.2 Size. 5
4.3 Intended clinical use designation . 5
5 Intended performance . 5
6 Design attributes. 5
6.1 General. 5
6.2 Delivery system and stent system . 6
6.3 Implant . 6
7 Materials . 7
8 Design evaluation . 8
8.1 General. 8
8.2 Sampling. 8
8.3 Conditioning of test samples . 9
8.4 Reporting . 9
8.5 Delivery system and stent system . 10
8.6 Stent . 15
8.7 Preclinical in vivo evaluation. 24
8.8 Clinical evaluation . 28
9 Post market surveillance . 31
10 Manufacturing . 32
11 Sterilization. 32
11.1 Products supplied sterile. 32
11.2 Products supplied non-sterile . 32
11.3 Sterilization residuals. 32
12 Packaging . 32
12.1 Protection from damage in storage and transport. 32
12.2 Marking . 33
12.3 Information supplied by the manufacturer . 34
Annex A (informative) Attributes of endovascular devices — Vascular stents — Technical and
clinical considerations . 36
Annex B (informative) Bench and analytical tests. 42
Annex C (informative) Definitions of reportable clinical events. 45
Annex D (informative) Test methods. 48
Annex E (informative) Supplement to fatigue durability test analytical approach. 86
Bibliography . 89
...