EN ISO 25539-2:2012

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)

2011-12-06 EMA: Draft for // vote received in ISO/CS (see notification of 2011-12-02 in dataservice).
MINOR REVISION      MINOR REVISION       MINOR REVISION       MINOR REVISION      MINOR REVISION

Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2012)

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 Teils von ISO 25539 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.
1.4   Verfahren und Implantate, die vor der Einführung des Gefäßstents verwendet wurden, wie z. B. durch Ballonangioplastie eingebrachte Implantate, sind vom Anwendungsbereich dieses Teils der ISO 25539 aus-geschlossen.
1.5   Einige pharmakologische Aspekte von medikamentenbeschichteten Stents werden in diesem Teil der ISO 25539 angesprochen, dieser Teil von ISO 25539 behandelt jedoch nicht umfassend die pharmako-logische Bewer¬tung medikamentenbeschichteter Stents.
1.6   Abbau und weitere zeitabhängige Aspekte von bioabsorbierbaren Stents und Beschichtungen sowie von Polymerstents und -beschichtungen werden in diesem Teil der ISO 25539 nicht behandelt.
1.7   Mit Ausnahme der Sterilisation behandelt dieser Teil der ISO 25539 keine Anforderungen an die Bewer¬tung von Produkten aus tierischem Gewebe.

Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Endoprothèses vasculaires (ISO 25539-2:2012)

L'ISO 25539-2:2012 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 25539-2:2012 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.
À l'exception de la stérilisation, l'ISO 25539-2:2012 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 25539-2:2012)

Ta del standarda ISO 25539 določa zahteve za žilne opornice, ki temeljijo na trenutnem medicinskem znanju. V zvezi z varnostjo podaja zahteve za predvidene lastnosti, obliko, materiale, vrednotenje oblike, izdelavo, sterilizacijo, pakiranje in informacije, ki jih zagotovi proizvajalec. Šteje se za dodatek k standardu ISO 14630, ki določa splošne zahteve za lastnosti neaktivnih kirurških vsadkov. Področje uporabe tega dela standarda ISO 25539 vključuje žilne opornice za zdravljenje žilnih lezij ali stenoz ali drugih žilnih anomalij. Te naprave lahko vključujejo ali ne vključujejo površinskih sprememb opornice, na primer zdravil in/ali drugih prevlek. Opornice, prekrite z materiali, ki znatno spremenijo prepustnost neprekrite opornice, spadajo na področje uporabe standarda ISO 25539-1. Zaradi oblike opornice je morda potrebna obravnava funkcionalnih zahtev, ki so opredeljene v standardu ISO 25539-1 in tem delu standarda ISO 25539. Sistemi dovajanja so vključeni v ta del standarda ISO 25539, če so sestavni del namestitve žilne opornice. Postopki in naprave, ki se uporabljajo pred vstavljanjem žilne opornice, na primer naprave za angioplastiko, ne spadajo na področje uporabe tega dela standarda ISO 25539. Nekateri farmakološki vidiki opornic z elucijo zdravil so obravnavani v tem delu standarda ISO 25539, vendar ta del standarda ISO 25539 ni izčrpen na področju farmakološkega vrednotenja opornic z elucijo zdravil. Razgradnja in drugi časovno odvisni vidiki bioresorbilnih in polimernih opornic ter prevlek v tem delu standarda ISO 25539 niso obravnavani. Z izjemo sterilizacije ta del standarda ISO 25539 ne obravnava zahtev za vrednotenje izdelkov iz živalskega tkiva.

General Information

• Status: Withdrawn
• Publication Date: 30-Nov-2012
• Withdrawal Date: 29-Sep-2020
• 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: 30-Sep-2020
• 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 25539-2:2013 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)

Relations

• Replaces: EN ISO 25539-2:2009 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
• Effective Date: 26-Dec-2012
• Replaces: EN ISO 25539-2:2009/AC:2011 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
• Effective Date: 26-Dec-2012
• Replaced By: EN ISO 25539-2:2020 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
• Effective Date: 18-Oct-2017

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2013
1DGRPHãþD
SIST EN ISO 25539-2:2009
SIST EN ISO 25539-2:2009/AC:2011
9VDGNLLPSODQWDWL]DVUFHLQRåLOMH=QRWUDMåLOQLSULSRPRþNLGHOäLOQHRSRUQLFH
VWHQW,62
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-
2:2012)
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539
-2:2012)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Endoprothèses
vasculaires (ISO 25539-2:2012)
Ta slovenski standard je istoveten z: EN ISO 25539-2:2012
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
December 2012
ICS 11.040.40 Supersedes EN ISO 25539-2:2009
English Version
Cardiovascular implants - Endovascular devices - Part 2:
Vascular stents (ISO 25539-2:2012)
Implants cardiovasculaires - Dispositifs endovasculaires - Kardiovaskuläre Implantate - Endovaskuläre Implantate -
Partie 2: Endoprothèses vasculaires (ISO 25539-2:2012) Teil 2: Gefäßstents (ISO 25539-2:2012)
This European Standard was approved by CEN on 30 November 2012.

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-CENELEC 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-CENELEC Management Centre has the same
status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 25539-2:2012: 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 25539-2:2012) 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 June 2013, and conflicting national standards shall be withdrawn at
the latest by June 2013.
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 25539-2:2009.
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 organisations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 25539-2:2012 has been approved by CEN as a EN ISO 25539-2:2012 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 one means of conforming to Essential Requirements of
the New Approach Directive 93/42/EEC, Medical devices.
Once this standard is cited in the Official Journal of the European Union 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.1 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.1 — Correspondence between Directive 93/42/EEC and this European Standard
Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/notes
this European Standard Directive 93/42/EEC
6,8,10 and 12 7.2
6.3 and 7 7.3
st
6 7.5 1 sentence
6 and 7 7.6
7 8.2
12.1.5 8.3
11.1 8.4
11.2 8.5
nd
6 and 7 9.2, 2 indent
12.2.2 13.3 a)
12.2.2 13.3 b)
12.2.2 13.3 c)
12.2.2 13.3 d)
12.2.2 13.3 e)
12.2.2 13.3 f)
12.2.2 13.3 i)
12.2.2 13.3 k)
12.2.2 13.3 m)
5 13.5
12.3.2 13.6 g)
12.3.2 13.6 k)
12.3.2 13.6 q)
WARNING: Other requirements and other EU Directives may be applicable to the products falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 25539-2
Second edition
2012-12-01
Cardiovascular implants — Endovascular
devices — Part 2: Vascular stents
Part 2:
Vascular stent
Implants cardiovasculaires — Dispositifs endovasculaires —
Partie 2: Endoprothèses vasculaires
Reference number
ISO 25539-2:2012(E)
©
ISO 2012
ISO 25539-2:2012(E)
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
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Published in Switzerland
ii © ISO 2012 – All rights reserved

ISO 25539-2:2012(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 . 4
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 . 7
8.1 General . 7
8.2 Sampling . 8
8.3 Conditioning of test samples . 8
8.4 Reporting . 8
8.5 Delivery system and stent system . 9
8.6 Stent .15
8.7 Preclinical in vivo evaluation .23
8.8 Clinical evaluation .27
9 Post-market surveillance .30
10 Manufacturing .30
11 Sterilization .30
11.1 Products supplied sterile .30
11.2 Products supplied non-sterile .31
11.3 Sterilization residuals .31
12 Packaging .31
12.1 Protection from damage in storage and transport .31
12.2 Marking .31
12.3 Information supplied by the manufacturer .32
Annex A (informative) Attributes of endovascular devices — Vascular stents — Technical and
clinical consideration .34
Annex B (informative) Bench and analytical tests .41
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 .85
Bibliography .88
ISO 25539-2:2012(E)
Foreword
ISO (the International Organization for Stand
...