SIST EN ISO 25539-2:2009
(Main)Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)
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.
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
Anforderungen an Gefäßstents fest. Im Hinblick auf die Sicherheit enthält sie 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. 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
vaskulärer Läsionen oder Stenosen oder sonstiger vaskulärer Anomalien eingesetzt werden. Bei diesen
Implantaten können Oberflächenmodifikationen des Stents, wie z. B. Medikamenten- und/oder weitere
Beschichtungen vorliegen. Stents, die mit Materialien ummantelt sind, die die Durchlässigkeit eines nicht
ummantelten Stents signifikant modifizieren, liegen im Anwendungsbereich der ISO 25539-1. Die Stentkonstruktion
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
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Stents vasculaires (ISO 25539-2:2008)
L'ISO 25539-2:2008 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 25539-2:2008 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. Les stents recouverts de matériaux qui modifient sensiblement l'étanchéité du stent nu sont compris dans le domaine d'application de l'ISO 25539-1:2003. La conception des stents peut rendre nécessaire d'analyser les exigences fonctionnelles identifiées à la fois dans l'ISO 25539-1:2003 et dans l'ISO 25539-2:2008.
Les systèmes d'injection sont inclus dans l'ISO 25539-2:2008 s'ils comprennent un composant intégral du déploiement du stent vasculaire.
Certains aspects pharmacologiques des stents à élution de médicaments sont traités dans l'ISO 25539-2:2008, mais celle-ci ne détaille pas l'évaluation pharmacologique de ce type de stent.
À l'exception de la stérilisation, l'ISO 25539-2:2008 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 25539-2:2008)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 25539-2:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 25539-2:2008
9VDGNL LPSODQWDWL ]DVUFHLQRåLOMH=QRWUDMåLOQLSULSRPRþNLGHO äLOQHRSRUQLFH
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: Stents vasculaires
(ISO 25539-2:2008)
Ta slovenski standard je istoveten z: EN ISO 25539-2:2009
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 25539-2:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 25539-2:2009
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SIST EN ISO 25539-2:2009
EUROPEAN STANDARD
EN ISO 25539-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 25539-2:2008
English Version
Cardiovascular implants - Endovascular devices - Part 2:
Vascular stents (ISO 25539-2:2008)
Implants cardiovasculaires - Dispositifs endovasculaires - Kardiovaskuläre Implantate - Endovaskuläre Implantate -
Partie 2: Stents vasculaires (ISO 25539-2:2008) Teil 2: Gefäßstents (ISO 25539-2:2008)
This European Standard was approved by CEN on 20 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 25539-2:2009: E
worldwide for CEN national Members.
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SIST EN ISO 25539-2:2009
EN ISO 25539-2:2009 (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 25539-2:2009
EN ISO 25539-2:2009 (E)
Foreword
The text of ISO 25539-2:2008 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 25539-2:2009
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 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 25539-2:2008.
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 25539-2:2008 has been approved by CEN as a EN ISO 25539-2:2009 without any
modification.
3
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SIST EN ISO 25539-2:2009
EN ISO 25539-2:2009 (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 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, 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, 6a., 7.1, 7.2, 8, 9.2,
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 Part of 13.3 a relating to the
authorised representative is not
covered.
Part of ER 13.3 f concerning
single use is not addressed in
this European Standard.
13.6 h) concerning 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.
4
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SIST EN ISO 25539-2:2009
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
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SIST EN ISO 25539-2:2009
ISO 25539-2:2008(E)
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ii © ISO 2008 – All rights reserved
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SIST EN ISO 25539-2:2009
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
© ISO 2008 – All rights reserved iii
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SIST EN ISO 25539-2:2009
ISO 25539-2:2008(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.
ISO 25539 consists of the following parts, under the general title Cardiovascular implants — Endovascular
devices:
⎯ Part 1: Endovascular prostheses
⎯ Part 2: Vascular stents
iv © ISO 2008 – All rights reserved
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SIST EN ISO 25539-2:2009
ISO 25539-2:2008(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 proposed three-part
standard. ISO 25539-1 addresses endovascular prostheses and ISO 25539-3 will address vena cava filters.
ISO/TS 15539, from which this part of ISO 25539 is derived, serves as a rationale for the requirements of this
document. 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 2008 – All rights reserved v
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SIST EN ISO 25539-2:2009
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SIST EN ISO 25539-2:2009
INTERNATIONAL STANDARD ISO 25539-2:2008(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 document 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
document 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 (all parts), Biological evaluation of medical devices
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 2008 – All rights reserved 1
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SIST EN ISO 25539-2:2009
ISO 25539-2:2008(E)
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 (both parts), Packaging for terminally sterilized medical devices
ISO 14155 (both parts), Clinical investigation of medical devices for human subjects
ISO 14160, Sterilization of single-use medical devices incorporating materials of animal origin — Validation
and routine control of sterilization by liquid chemical sterilants
ISO 14630, 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
ISO 14971, 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
2 © ISO 2008 – All rights reserved
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SIST EN ISO 25539-2:2009
ISO 25539-2:2008(E)
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.
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
© ISO 2008 – All rights reserved 3
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SIST EN ISO 25539-2:2009
ISO 25539-2:2008(E)
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
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 parts 1 and 2 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 parts 1 and 2 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 © ISO 2008 – All rights reserved
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SIST EN ISO 25539-2:2009
ISO 25539-2:2008(E)
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.
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 of ISO 14630 shall apply.
6 Design attributes
6.1 General
The requirements for design attributes of ISO 14630 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;
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SIST EN ISO 25539-2:2009
ISO 25539-2:2008(E)
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.
[15]
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 recognised that not all tests identified in a
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 intended performance of the delivery system shall additionally take into
account at least the following:
a) the ability of the system to permit consistent, accurate and safe access to the intended location
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2008)Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Stents vasculaires (ISO 25539-2:2008)Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2008)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:prEN ISO 25539-2kSIST prEN ISO 25539-2:2009en01-marec-2009kSIST prEN ISO 25539-2:2009SLOVENSKI
STANDARD
kSIST prEN ISO 25539-2:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN ISO 25539-2December 2008ICS 11.040.40Will supersede EN ISO 25539-2:2008
English VersionCardiovascular implants - Endovascular devices - Part 2:Vascular stents (ISO 25539-2:2008)Implants cardiovasculaires - Dispositifs endovasculaires -Partie 2: Stents vasculaires (ISO 25539-2:2008)Kardiovaskuläre Implantate - Endovaskuläre Implantate -Teil 2: Gefäßstents (ISO 25539-2:2008)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 285.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame 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.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 25539-2:2008: EkSIST prEN ISO 25539-2:2009
prEN ISO 25539-2:2008 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 kSIST prEN ISO 25539-2:2009
prEN ISO 25539-2:2008 (E) 3 Foreword The text of ISO 25539-2:2008 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 prEN ISO 25539-2:2008 by Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede EN ISO 25539-2:2008. 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 EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. Endorsement notice The text of ISO 25539-2:2008 has been approved by CEN as a prEN ISO 25539-2:2008 without any modification.
kSIST prEN ISO 25539-2:2009
prEN ISO 25539-2:2008 (E) 4 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 EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 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, 6a., 7.1, 7.2, 8, 9.2,
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 Part of 13.3 a relating to the authorised representative is not covered.
Part of ER 13.3 f concerning single use is not addressed in this European Standard.
13.6 h) concerning 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. kSIST prEN ISO 25539-2:2009
Reference numberISO 25539-2:2008(E)© ISO 2008
INTERNATIONAL STANDARD ISO25539-2First edition2008-09-01Cardiovascular implants — Endovascular devices — Part 2: Vascular stents Implants cardiovasculaires — Dispositifs endovasculaires — Partie 2: Endoprothèses vasculaires
kSIST prEN ISO 25539-2:2009
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ii © ISO 2008 – All rights reserved
kSIST prEN ISO 25539-2:2009
ISO 25539-2:2008(E) © ISO 2008 – All rights reserved iiiContents 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
kSIST prEN ISO 25539-2:2009
ISO 25539-2:2008(E) iv © ISO 2008 – All rights reserved 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. ISO 25539 consists of the following parts, under the general title Cardiovascular implants — Endovascular devices: ⎯ Part 1: Endovascular prostheses ⎯ Part 2: Vascular stents
kSIST prEN ISO 25539-2:2009
ISO 25539-2:2008(E) © ISO 2008 – All rights reserved vIntroduction 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 proposed three-part standard. ISO 25539-1 addresses endovascular prostheses and ISO 25539-3 will address vena cava filters. ISO/TS 15539, from which this part of ISO 25539 is derived, serves as a rationale for the requirements of this document. 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.
kSIST prEN ISO 25539-2:2009
kSIST prEN ISO 25539-2:2009
INTERNATIONAL STANDARD ISO 25539-2:2008(E) © ISO 2008 – All rights reserved 1Cardiovascular 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 document 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 document 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 (all parts), Biological evaluation of medical devices 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 kSIST prEN ISO 25539-2:2009
ISO 25539-2:2008(E) 2 © ISO 2008 – All rights reserved 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 (both parts), Packaging for terminally sterilized medical devices ISO 14155 (both parts), Clinical investigation of medical devices for human subjects ISO 14160, Sterilization of single-use medical devices incorporating materials of animal origin — Validation and routine control of sterilization by liquid chemical sterilants ISO 14630, 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 ISO 14971, 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 kSIST prEN ISO 25539-2:2009
ISO 25539-2:2008(E) © ISO 2008 – All rights reserved 33.6 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. 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 kSIST prEN ISO 25539-2:2009
ISO 25539-2:2008(E) 4 © ISO 2008 – All rights reserved 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 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 parts 1 and 2 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 parts 1 and 2 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. kSIST prEN ISO 25539-2:2009
ISO 25539-2:2008(E) © ISO 2008 – All rights reserved 54.2 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. 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 of ISO 14630 shall apply. 6 Design attributes 6.1 General The requirements for design attributes of ISO 14630 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; kSIST prEN ISO 25539-2:2009
ISO 25539-2:2008(E) 6 © ISO 2008 – All rights reserved 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. NOTE These additional items are adapted from Clause 5 of EN 12006-3:1998[15]. 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 recognised that not all tests identified in a 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 intended performance of the delivery system shall additionally take into account at least the following: a) the ability of the system to permit consistent, accurate and safe access to the intended location; b) the ability of the system to permit consistent, accurate and safe deployment of the stent; c) the ability of the system to permit consistent and safe withdrawal of the delivery system; d) the compliance of the system with the requirements of ISO 10993-1 and appropriate other parts of the ISO 10993 series of International Standards (biocompatibility); e) the ability of the system to minimise blood loss (haemostasis); f) the visibility of the system under fluoroscopy or other technologies. 6.3 Implant 6.3.1 Stent The design attributes to meet the intended performance of the stent shall additionally take into account at least the following: a) the ability of the stent to be consistently, accurately and safely deployed; b) the ability of the stent to ensure effective fixation and apposition in the intended location within the vasculature; c) the ability of the stent to maintain adequate integrity; d) the consistency of the stent dimensions and its design for compatibility for use in specified vessel diameters; e) the ability of the stent to maintain adequate blood flow through the lumen (patency); f) the compatibility of the stent with exposure to magnetic resonance imaging (MRI) fields; kSIST prEN ISO 25539-2:2009
ISO 25539-2:2008(E) © ISO 2008 – All rights reserved 7g) the compliance of the stent with the requirements of ISO 10993-1 and appropriate other parts of the ISO 10993 series of International Standards (biocompatibility); h) the visibility of the stent under fluoroscopy or other technologies. 6.3.2 Coating The design attributes to meet the intended performance of the coating shall additionally take into account at least the following: a) the ability of the coating to maintain adequate integrity over time according to design specifications (e.g. freedom from significant delamination, flaps and bare spots); b) the appropriate interaction between the coating and the stent (e.g. coating influenced corrosion of the substrate); c) the ability of the coating to maintain adequate resistance to unintended particulate generation; d) the conformance of the coating dimensions and other coating parameters (e.g. porosity, density, distribution) to the design requirements; e) the effect of MRI on the coating of a coated stent (e.g. heating). 6
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