SIST EN ISO 25539-2:2013

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

This part of ISO 25539 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 this part of ISO 25539 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. The stent design might dictate the need to address functional requirements identified in both ISO 25539-1 and this part of ISO 25539. Delivery systems are included in this part of ISO 25539 if they comprise an integral component of the deployment of the vascular stent. Procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices, are excluded from the scope of this part of ISO 25539. Some pharmacological aspects of drug-eluting stents are addressed in this part of ISO 25539, but this part of ISO 25539 is not comprehensive with respect to the pharmacological evaluation of drug-eluting stents. Degradation and other time-dependent aspects of bioabsorbable and polymeric stents and coatings are not addressed by this part of ISO 25539. With the exception of sterilization, this part of ISO 25539 does not address requirements for the evaluation of animal tissue products.

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
• Public Enquiry End Date: 19-Oct-2012
• Publication Date: 14-Feb-2013
• Withdrawal Date: 19-Oct-2020
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 20-Oct-2020
• Due Date: 12-Nov-2020
• Completion Date: 20-Oct-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: EN ISO 25539-2:2012 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2012)

Relations

• Replaced By: SIST EN ISO 25539-2:2020 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
• Effective Date: 01-Nov-2020
• Replaced By: SIST EN ISO 25539-2:2020 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN ISO 25539-2:2009/AC:2011 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
• Effective Date: 01-Mar-2013
• Replaces: SIST EN ISO 25539-2:2009 - Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
• Effective Date: 01-Mar-2013

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 25539-2:2013
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
SIST EN ISO 25539-2:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 25539-2:2013

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SIST EN ISO 25539-2:2013


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.

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SIST EN ISO 25539-2:2013
EN ISO 25539-2:2012 (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 25539-2:2013
EN ISO 25539-2:2012 (E)
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.
3

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SIST EN ISO 25539-2:2013
EN ISO 25539-2:2012 (E)
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.
4

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SIST EN ISO 25539-2:2013
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

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SIST EN ISO 25539-2:2013
ISO 25539-2:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
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]
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved

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SIST EN ISO 25539-2:2013
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 2012 – All rights reserved iii

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SIST EN ISO 25539-2:2013
ISO 25539-2:2012(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 a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 25539-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants and extracorporeal systems.
This second edition cancels and replaces the first edition (ISO 25539-2:2008), of which it constitutes a minor
revision. This minor revision updates the normative references and provides minor editorial changes to Clause 8
and Annex D for clarification.
ISO 25539 consists of the following parts, under the general title Cardiovascular implants — Endovascular devices:
— Part 1: Endovascular prostheses
— Part 2: Vascular stents
— Part 3: Vena cava filters
iv © ISO 2012 – All rights reserved

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SIST EN ISO 25539-2:2013
ISO 25539-2:2012(E)
Introduction
This part of ISO 25539 has been prepared in order to provide minimum requirements for endovascular devices
and the methods of test that will enable their evaluation. It is the second part of a three-part standard. ISO 25539-1
addresses endovascular prostheses and ISO 25539-3 addresses vena cava filters. ISO/TS 15539, from which
this part of ISO 25539 is derived, serves as a rationale for the requirements of this part of ISO 25539. The
Technical Specification ISO/TS 15539 was developed by first identifying the design requirements for these
devices and listing the potential device and clinical failure modes. Tests were then identified to address each of
the failure modes. The requirements provided in this part of ISO 25539 are based on that assessment.
© ISO 2012 – All rights reserved v

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SIST EN ISO 25539-2:2013

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SIST EN ISO 25539-2:2013
INTERNATIONAL STANDARD ISO 25539-2:2012(E)
Cardiovascular implants — Endovascular devices —
Part 2:
Vascular stents
1 Scope
1.1 This part of ISO 25539 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.
NOTE Due to the variations in the design of implants covered by this part of ISO 25539 and in some cases due to
the relatively recent development of some of these implants (e.g. bioabsorbable stents, polymeric stents), acceptable
standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become
available, appropriate revision of this part of ISO 25539 will be necessary.
1.2 The scope of this part of ISO 25539 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. The stent design might dictate the need to address
functional requirements identified in both ISO 25539-1 and this part of ISO 25539.
1.3 Delivery systems are included in this part of ISO 25539 if they comprise an integral component of the
deployment of the vascular stent.
1.4 Procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty
devices, are excluded from the scope of this part of ISO 25539.
1.5 Some pharmacological aspects of drug-eluting stents are addressed in this part of ISO 25539, but this
part of ISO 25539 is not comprehensive with respect to the pharmacological evaluation of drug-eluting stents.
1.6 Degradation and other time-dependent aspects of bioabsorbable and polymeric stents and coatings
are not addressed by this part of ISO 25539.
1.7 With the exception of sterilization, this part of ISO 25539 does not address requirements for the
evaluation of animal tissue products.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
ISO 10993-1 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
© ISO 2012 – All rights reserved 1

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SIST EN ISO 25539-2:2013
ISO 25539-2:2012(E)
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming,
sealing and assembly processes
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14160, Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical
devices utilizing animal tissues and their derivatives — Requirements for characterization, development,
validation and routine control of a sterilization process for m ISO 14630:2012, Non-active surgical implants — General requirements
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions in ISO 14630 and the following apply.
NOTE Bench and analytical tests are described in Annex B. Reportable clinical events are defined in Annex C.
3.1
balloon-assisted deployment
use of a balloon to facilitate the complete deployment (or expansion) of a self-expanding stent
3.2
balloon winging
cross-sectional shape of the balloon when deflated which can cause problems during withdrawal
NOTE Examples include stent migration, damage to host vessel or balloon, and inability to remove the balloon.
3.3
delivery system
system or mechanism used to deliver the stent to the targeted position and to deploy the stent
NOTE The delivery system is removed after stent placement. Examples of delivery systems include balloon catheters
or mechanically activated systems.
3.4
determine
to quantitatively appraise or analyse
NOTE Also see evaluate (3.8).
3.5
dogboning
dumbbell-shaped balloon observed during stent deployment when the unconstrained ends of the balloon
expand beyond the dilated stent outer diameter
3.6
coating
organic or inorganic material, other than living cells, intentionally applied by a manufacturer to a substrate
NOTE This coating can be intended to be permanent or temporary, and can be applied to the external and/or
internal surface.
2 © ISO 2012 – All rights reserved

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SIST EN ISO 25539-2:2013
ISO 25539-2:2012(E)
3.7
drug content
amount of drug present on the surface(s) of a coating, as part of a coating or within the stent
3.8
evaluate
to qualitatively appraise or analyse
NOTE Also see determine (3.4).
3.9
lumen reduction
reduction of diameter or cross sectional area as observed by imaging
3.10
reportable clinical events
complications, failures or device-related observations, including all adverse events and adverse device effects,
that might be observed with clinical use of the stent system
NOTE Examples are listed in Annex C. These events might not have clinical significance and might not be attributable
to the device.
3.11
stent configuration
stent shape (e.g. cylindrical, tapered, flared, coiled, segmented, bifurcated)
3.12
stent outer surface area
contact area between the stent and the vessel
3.13
stent-free surface area
percentage of surface area of cylinder formed by the implant frame, which is not covered by implant material
3.14
stent system
vascular stent and its delivery system or a vascular stent mounted on the delivery balloon as specified in the
instructions for use (IFU)
3.15
vascular stent
stent
implant
transluminally placed balloon-expandable or self-expanding implant, which is used to treat vascular lesions by
providing a mechanical support after deployment to maintain or restore vessel integrity
NOTE 1 Stents can or cannot incorporate surface modifications of the stent such as drug and/or other coatings.
NOTE 2 The following stent types are within the scope of this part of ISO 25539.
3.15.1
articulated stent
stent constructed of segments with distinct connections
3.15.2
bare stent
stent without a coating or covering
NOTE Bare stents can be constructed of single or multiple materials.
3.15.3
bioabsorbable stent
stent that is designed to be a temporary structure without requiring explantation
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SIST EN ISO 25539-2:2013
ISO 25539-2:2012(E)
3.15.4
balloon-expandable stent
stent where the diameter is increased from its pre-deployed size to its post-deployed size with the aid of a
balloon catheter
3.15.5
coated stent
stent with a surface layer of an additional material(s) that does not provide significant (e.g. more than 5 %)
structural support or appreciably reduce the permeability or stent-free surface area of the bare stent
3.15.6
composite stent
stent consisting of more than one material or material compound that provides significant (e.g. more than 5 %)
overall structural support upon deployment
3.15.7
covered stent
stent covered with an additional material(s) that appreciably reduces the permeability and/or eliminates the
stent-free surface area of the bare stent
NOTE Covered stents are within the scope of ISO 25539-1. The stent design might dictate the need to address
functional requirements identified in both ISO 25539-1 and this part of ISO 25539.
3.15.8
drug-eluting stent
DES
stent that delivers a drug(s) over time
3.15.9
self-expanding stent
stent where the diameter increases from its pre-deployed size to its post-deployed size when released from the
delivery mechanism in absence of balloon inflation or other mechanical assistance
NOTE Self-expanding stents are within the scope of ISO 25539-1. The stent design might dictate the need to address
functional requirements identified in both ISO 25539-1 and this part of ISO 25539.
4 General requirements
4.1 Classification
A stent shall be designated by its configuration (see 3.11), type (see 3.15), materials of construction, and any
surface modifications, coatings, and/or drugs.
4.2 Size
The size of a stent shall be designated by the following characteristics:
a) external diameter;
1) self-expanding:
i) unconstrained external diameter of the device, expressed in millimetres;
ii) intended vessel lumen diameter range, expressed in millimetres;
2) balloon expandable: range of intended expanded internal diameters;
b) minimum and maximum usable length, expressed in millimetres or centimetres.
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SIST EN ISO 25539-2:2013
ISO 25539-2:2012(E)
4.3 Intended clinical use designation
The intended clinical use shall be designated by one or more of the following:
a) abdominal aorta;
b) arterio-venous shunt for vascular access;
c) carotid;
d) coronary;
e) femoral;
f) iliac;
g) popliteal;
h) renal;
i) thoracic aorta;
j) thoraco-abdominal aorta;
k) tibial;
l) other arterial vessels to be specified;
m) other venous vessels to be specified.
5 Intended performance
The requirements for intended performance specified in ISO 14630:2012, Clause 4, shall apply.
6 Design attributes
6.1 General
The requirements for design attributes of ISO 14630:2012, Clause 5, apply. In addition, the following shall be
taken into account:
a) oxidation-potential, the possibility of crevice corrosion, passivation over the relevant parts;
b) fretting, galvanic and pitting corrosion;
c) interface between implant and body:
1) fixation hooks, if present;
2) relative movement between stent and tissue;
3) forces exerted by the stent on the surrounding tissue;
4) forces required to deform the stent if the deformation is permanent;
d) expected ingrowth, penetration, perforation, tilting and migration; introduction and delivery systems.
[14]
NOTE These additional items are adapted from Clause 5 of EN 12006-3:1998 .
The design attributes for vascular stents (with or without delivery system) are listed in Table A.2 with reference
to the test sections for the evaluation of the design (Clause 8). It is recognized that not all tests identified in a
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category will be necessary or practical for any given stent and/or delivery system. The tests considered and
the rationale for selection and/or waiving of tests shall be recorded.
6.2 Delivery system and stent system
The design attributes to meet the int
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