EN ISO 25539-1:2009

SLOVENSKI STANDARD
01-julij-2009
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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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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
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, 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 25539-1:2003, including Amd 1:2005 has been approved by CEN as a EN ISO 25539-1:2009
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 on medical devices.
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) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
4 1 - 2 -3 - 4 - 7.1
5 1 - 2 - 3 - 4 - 5 - 7.1 - 7.2 - 7.3 -
7.5 - 7.6 - 8 - 9.1 - 9.2
6 1 - 2 - 7.1 - 7.2 - 7.3 - 7.4 - 7.5 - ER 7.4 includes a mandatory
7.6 - 8.2 - 9.2 consultation of regulatory
authorities in relation to
medicinal substances that is not
addressed in this European
Standard.
7 1 - 2 - 3 - 4 - 6 - 6a. - 7.1 - 7.2 -
7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2
8 1 - 2 - 3 - 5 - 7.1 - 7.2
9 1 - 2 - 7.2 - 8.1 - 8.2 - 8.3 - 8.4
10.1 1 - 2 - 3 - 5 - 7.2 - 7.3 - 7.4 - 7.6 - ER 7.4 includes a mandatory
8.3 - 8.4 consultation of regulatory
authorities in relation to
medicinal substances that is not
addressed in this European
Standard.
10.2 - 10.3 1 - 2 - 8.7 - 9.1 - 13 The part of ER 13.3.a
concerning the information of the
authorized representative is not
addressed in this European
Standard.
Part of ER 13.3 f relating to
single use is not addressed in
this European Standard.
Part of ER 13.6 h) relating to
single use is not addressed in
this European Standard.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 25539-1
First edition
2003-03-01
Cardiovascular implants — Endovascular
devices —
Part 1:
Endovascular prostheses
Implants cardiovasculaires — Dispositifs endovasculaires —
Partie 1: Prothèses endovasculaires

Reference number
ISO 25539-1:2003(E)
©
ISO 2003
ISO 25539-1:2003(E)
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ISO 25539-1:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 Intended performance. 3
5 Design attributes. 3
5.1 General. 3
5.2 Delivery system. 4
5.3 Implant. 4
6 Materials. 4
7 Design evaluation. 5
7.1 General. 5
7.2 Delivery (and/or endovascular) system . 5
7.3 Implant. 11
7.4 Preclinical in vivo evaluation. 19
7.5 Clinical evaluation. 22
8 Manufacturing. 25
9 Sterilization. 25
9.1 Products supplied sterile. 25
9.2 Products supplied non-sterile. 26
9.3 Sterilization residuals. 26
10 Packaging. 26
10.1 Protection from damage in storage and transport . 26
10.2 Marking. 27
10.3 Information supplied by the manufacturer. 27
Annex A (informative) Attributes of endovascular devices— Technical and clinical considerations. 29
Annex B (informative) Bench and analytical tests . 36
Annex C (informative) Definitions of reportable clinical events. 39
Bibliography . 42

ISO 25539-1:2003(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which
...