SIST EN ISO 25539-2:2020

SLOVENSKI STANDARD
01-november-2020
Nadomešča:
SIST EN ISO 25539-2:2013
Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 2. del: Žilne opornice
(stent) (ISO 25539-2:2020)
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-
2:2020)
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539
-2:2020)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Endoprothèses
vasculaires (ISO 25539-2:2020)
Ta slovenski standard je istoveten z: EN ISO 25539-2:2020
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.

EN ISO 25539-2
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2020
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 25539-2:2012
English Version
Cardiovascular implants - Endovascular devices - Part 2:
Vascular stents (ISO 25539-2:2020)
Implants cardiovasculaires - Dispositifs Kardiovaskuläre Implantate - Endovaskuläre
endovasculaires - Partie 2: Endoprothèses vasculaires Implantate - Teil 2: Gefäßstents (ISO 25539-2:2020)
(ISO 25539-2:2020)
This European Standard was approved by CEN on 20 August 2020.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 25539-2:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 25539-2:2020) has been prepared by Technical Committee ISO/TC 150
"Implants for surgery" in collaboration with Technical Committee CEN/TC 285 “Non-active surgical
implants” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by March 2021, and conflicting national standards shall
be withdrawn at the latest by March 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 25539-2:2012.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 25539-2:2020 has been approved by CEN as EN ISO 25539-2:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 25539-2
Third edition
2020-09
Cardiovascular implants —
Endovascular devices —
Part 2:
Vascular stents
Implants cardiovasculaires — Dispositifs endovasculaires —
Partie 2: Endoprothèses vasculaires
Reference number
ISO 25539-2:2020(E)
©
ISO 2020
ISO 25539-2:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO 25539-2:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 2
4 General requirements for stent systems . 6
4.1 General . 6
4.2 Type of stent . 6
4.3 Materials of construction for stent system . 6
4.4 Configuration and size designation for stents and stent systems . 6
4.5 Intended clinical use designation . 7
4.6 Balloon designation . 8
5 Intended performance . 8
6 Design attributes . 8
6.1 General . 8
6.2 Stent system . 8
6.3 Stent. 8
6.4 Stent system and stent . 9
6.5 Coating on delivery system or stent . 9
6.6 Coating on stent . 9
6.7 Absorbable stent or coating . 9
6.8 Drug-eluting stent .10
7 Materials .10
8 Design evaluation .10
8.1 General .10
8.2 Sampling .11
8.3 Conditioning of test samples .12
8.4 Reporting .12
8.5 Bench and analytical tests .13
8.5.1 Stent system and delivery system .13
8.5.2 Stent .16
8.5.3 Absorbable stents and stents containing an absorbable coating .22
8.5.4 Coating on a delivery system .22
8.5.5 Coating on a stent .22
8.5.6 Drug-containing stent.22
8.6 Preclinical in vivo evaluation .23
8.6.1 Purpose .23
8.6.2 Specific aims .23
8.6.3 Protocol considerations .24
8.6.4 Data acquisition .24
8.6.5 Test report and additional information .26
8.7 Clinical evaluation .27
8.7.1 Purpose .27
8.7.2 Specific aims .27
8.7.3 Protocol considerations .28
8.7.4 Data acquisition .29
8.7.5 Final report .31
9 Post-market surveillance .32
10 Manufacturing .32
11 Sterilization .32
ISO 25539-2:2020(E)
11.1 Products supplied sterile .32
11.2 Sterilization residuals .33
12 Packaging .33
12.1  General .33
12.1.1 General.33
12.1.2 Unit container .33
12.1.3 Outer container .33
12.1.4 Shipping container .33
12.1.5 Maintenance of sterility in transit .33
12.2 Labelling .33
12.2.1 Container label .33
12.2.2 Stents without delivery systems .33
12.2.3 Stent systems (stents with delivery system) .34
12.2.4 Record label . .34
12.3 Information supplied by the manufacturer .34
12.3.1 General.34
12.3.2 Information and instructions for use for stents and/or stent systems .35
Annex A (informative) Relationship between testing requirements, device attributes, and
potential failure modes and guidance for the creation of a device evaluation strategy .36
Annex B (informative) Description of clinical effects of failure .53
Annex C (informative) Description of device effects of failure .56
Annex D (informative) Test methods .58
Bibliography .113
iv © ISO 2020 – All rights reserved

ISO 25539-2:2020(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 2, Cardiovascular implants and extracorporeal systems, in collaboration with the European Committee
for Standardization (CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in accordance
with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 25539-2:2012), which has been
technically revised.
The main changes compared to the previous edition are updates to the testing and clinical use of
vascular stents as well as improved consistency in nomenclature and reporting requirements.
A list of all parts in the ISO 25539 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
ISO 25539-2:2020(E)
Introduction
This document was prepared to provide minimum requirements for vascular stents. The rationale
for the requirements for bench tests and analyses to assess device performance, guidance on the
identification of appropriate testing to evaluate a specific device design, and guidance for developing
test methods are provided in informative annexes. Further clarification of terminology is provided in
additional informative annexes.
This document has been updated to reflect current knowledge regarding the testing and clinical use of
vascular stents, reflected in modifications to the requirements in the main body and in the guidance for
developing test methods in Annex D. In addition, revisions have been made to improve consistency in
nomenclature and reporting and to enhance the utility of this document.
Requirements particular to the evaluation of specific characteristics of stents (e.g. coatings, drug-
elution, absorption) are incorporated by reference to appropriate standards. However, not all tests
listed in the referenced standards are applicable to vascular stents. Only tests that address the design
attributes specified in Clause 6 are required for compliance to this document.
This revised document introduces methodology to identify appropriate testing and analyses for a
specific vascular stent, designated as the device evaluation strategy. The requirement regarding the
device evaluation strategy is in the main body. Annex A provides guidance for developing a focused
device evaluation strategy table that is specific to the unique characteristics of a device, device design
modifications, or changes in intended use. Annex A also provides guidance for the development of a
comprehensive device evaluation strategy table that may be used when it is not sufficient to focus only
on the unique characteristics or changes.
NOTE ISO 25539-1:2017 includes tables that can be used to justify the testing needed for device design
modifications and changes in intended use in Annex A. In this document, this concept is called a focused device
evaluation strategy table and can be applied to a new device as well as device design modifications or changes in
the intended use.
The other significant modifications in the requirements include the addition of non-radial durability
testing, with guidance on the selection of appropriate testing, and specific requirements for testing
to evaluate patency-related characteristics. Guidance for the development of appropriate tests to meet
these requirements is included in Annex D.
The guidance on the development of methods to address the requirement for evaluating fatigue and
durability through computational analyses has been modified significantly to include recommendations
regarding verification of the solution and validation of the computational model, as well as reporting.
The guidance on the model development for simulated use has also been significantly revised to
improve the clinical relevance of this testing.
The specific requirements to evaluate pushability, flexibility, torquability, trackability, and deployment
accuracy of a stent system have been removed and incorporated within the simulated use evaluation
requirement to better reflect how these attributes are evaluated. Similarly, the requirement to evaluate
tubing tensile strength has been removed and incorporated within the evaluation of tensile bond
strength.
In addition to modifications to specific design evaluation requirements, guidance has been provided
regarding the assessment of the acceptability of test results. When the requirement is to quantitatively
appraise or analyse a parameter, test results generally may be compared to a quantitative value (i.e.
acceptance criteria). For characterization tests it is appropriate to provide an explanation of the
relevance of the results. Additionally, some testing may include comparison to test data or existing data
from a previously evaluated device.
For design evaluation, requirements regarding sampling, conditioning of test samples, and reporting
have been incorporated in the main body. Guidance on these elements of testing and documentation
were previously only included in Annex D.
vi © ISO 2020 – All rights reserved

ISO 25539-2:2020(E)
The revisions to the annexes to this document are as follows:
Annex of ISO 25539-2:2012 Revision
Annex A — Attributes of endovascular devic- Annex A now includes the relationship between testing
es — Vascular stents — Technical and clinical requirements, device attributes, and potential failure
considerations modes and guidance for the creation of a device evaluation
strategy.
Annex B — Bench and analytical tests The list of tests is included in Table D.1.
Annex B now includes a description of potential clinical
effects of failure. Effects of failure for stents used with end-
ovascular prostheses are included.
Annex C — Definitions of reportable clinical The term “reportable” clinical events is no longer used in
events this document.
Annex C now includes a description of potential device
effects of failure. Effects of failure for stents used with end-
ovascular prostheses are included.
Annex D — Test methods This edition incorporates the sample equations as a supple-
ment to the radial fatigue durability test from ISO 25539-
2:2012, Annex E in Annex D.
Annex E — Supplement to the radial fatigue and There is no longer an Annex E as the sample equations as a
durability test analytical approach supplement to the fatigue durability test have been incorpo-
rated in Annex D.
It is recognized by this ISO committee that many stent systems have been shown to be safe and effective
in clinical use. This update is not intended to require additional evaluation of these devices to remain
in compliance with this document as the testing would not provide useful information regarding the
expected clinical performance of the device. Manufacturers may rely on historical data gathered under
the guidance of the previous edition of ISO 25539-2. Similarly, for device modifications or changes in
intended clinical use, this update is not intended to require additional evaluation of any aspects of the
device that are not expected to change clinical performance.
NOTE The relationship between testing requirements, device attributes, and potential failure modes is
provided in Clause A.1. Clause A.1 also provides general information regarding device evaluation strategies.
Tables A.2 and A.3 provide the rationale for the requirements specified in this document for bench tests and
analyses to assess device performance. An explanation of the table headings for A.2 and A.3 are described in
Table A.1.
Guidance for the creation of a device-specific evaluation strategy is provided in Clause A.2. Two approaches to
create a device-specific evaluation strategy are provided: 1) focused device evaluation strategy in A.2.1; and 2)
comprehensive device evaluation strategy in A.2.2.
Annex B provides a description of the potential clinical effects of failure identified in Annex A.
Annex C provides a description of the potential device effects of failure identified in Annex A.
Additional descriptions of clinical and device effects of failure are included in Annexes B and C, respectively.
Annex D provides information to consider in developing appropriate bench test and analytical methods.
INTERNATIONAL STANDARD ISO 25539-2:2020(E)
Cardiovascular implants — Endovascular devices —
Part 2:
Vascular stents
1 Scope
This document specifies requirements for the evaluation of stent systems (vascular stents and delivery
systems) and requirements with respect to nomenclature, design attributes and information supplied
by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro
test methods is included in Annex D. This document is supplemental to ISO 14630, which specifies
general requirements for the performance of non-active surgical implants.
NOTE 1 Due to the variations in the design of implants covered by this document, and in some cases due to
the emergence of novel types of such implants, 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.
This document is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular
scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of
the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent
systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this
document, comprehensive requirements and testing are not described for these uses. Similarly, specific
stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and
testing are not described for these devices.
Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion,
including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated
endovascular prosthesis), are within the scope of this document, but test methods are not described for
the combination. ISO 25539-1 also provides information relevant to the preclinical in vivo and clinical
evaluations of such stents.
Vascular stents that have surface modifications, such as drug and/or other coatings, are within the
scope of this document. Stents covered with materials that significantly modify the permeability of the
uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The
stent design or intended use might dictate the need to address functional requirements identified in
both ISO 25539-1 and this document (e.g. stents used in combination with endovascular prostheses,
stents used to treat aortic aneurysms).
Balloons integral to the stent system are within the scope of this document. This document provides
requirements beyond the requirements of ISO 10555-4, which are specific to the use of balloons with
vascular stents.
This document is not applicable to procedures and devices used prior to the introduction of the vascular
stent, such as balloon angioplasty devices.
Tacking devices intended to spot treat post-angioplasty dissections, coil supporting devices, and flow
diverters are within the scope of this document, but comprehensive requirements and testing are not
described for these devices.
Although drug-eluting stents are within the scope of this document, this document is not comprehensive
with respect to the drug-eluting properties of these devices.
NOTE 2 Vascular device-drug combination products are within the scope of ISO 12417-1.
ISO 25539-2:2020(E)
Although absorbable stents and stents with absorbable coatings are within the scope of this document,
this document is not comprehensive with respect to the absorbable properties of these devices.
NOTE 3 Absorbable implants are within the scope of ISO/TS 17137.
Although coated stents and coated stent systems are within the scope of this document, this document
is not comprehensive with respect to coatings.
NOTE 4 Some coating properties are within the scope of ISO 17327-1.
This document does not address the requirements for, and the evaluation of, viable tissues and non-
viable biologic materials used in the construction of vascular stents.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 — Part 1: Evaluation and testing within a
risk management process
ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 11137 (all parts), Sterilization of health care products — Radiation
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
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 medical devices
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 for medical devices
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
ASTM F2503, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic
Resonance Environment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 14630 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
2 © ISO 2020 – All rights reserved

ISO 25539-2:2020(E)
3.1
adverse event
unfavorable change in health that occurs in a subject who participates in a study while receiving the
treatment or within a specified time after receiving treatment
Note 1 to entry: For the purpose of this document, clinical effects of failure are a subset of adverse events and are
described separately.
Note 2 to entry: Adverse events are categorized by the system affected (e.g. cardiac, vascular, respiratory,
neurological, renal, gastro-intestinal) and the severity of the event.
3.2
post-dilation
use of a balloon to facilitate the complete deployment (or expansion) of a self-expanding stent (3.22.9)
3.3
bridging stent
vascular stent used in combination with an endovascular prosthesis to complete the treatment of a lesion
Note 1 to entry: See 3.22 for vascular stent.
3.4
clinical effect of failure
specific clinical observations potentially associated with device failures
Note 1 to entry: Clinical effects of failure are described in Annex B.
3.5
coating
additional layer of organic or inorganic material, other than living cells, on the surface of a substrate
that modifies its surface properties
Note 1 to entry: This coating can be intended to be permanent or temporary and can be applied to the external
and/or internal surface.
3.5.1
absorbable coating
coating (3.5) that is intended to be absorbed
Note 1 to entry: Drugs are excluded from this definition of absorbable coatings.
3.6
delivery system
system or mechanism used to deliver the stent to the targeted position and to deploy the stent
Note 1 to entry: The delivery system is removed after stent placement. Examples of delivery systems include
balloon catheters or mechanically activated systems.
3.7
determine
appraise or analyse quantitatively
Note 1 to entry: Also see evaluate (3.14).
3.8
device effects of failure
consequence to the device potentially associated with device failures
Note 1 to entry: Device effects of failure are described in Annex C.
ISO 25539-2:2020(E)
3.9
device evaluation strategy
rationale for the testing selected for a specific stent system, based on the requirements of the device
design and potential failure modes
3.10
comprehensive device evaluation strategy table
optional communication tool to present the device evaluation strategy for a specific stent system that
addresses all attributes and failure modes (3.15)
3.11
focused device evaluation strategy table
optional communication tool to present the device evaluation strategy for a specific stent system that
focuses on the unique characteristics of the device design or procedure and unique aspects of the
intended use
3.12
dogboning
dumbbell-shaped balloon observed when the unconstrained ends of the balloon expand beyond the
dilated stent outer diameter
3.13
drug
active pharmaceutical ingredient [pharmacologically active (drug or medicinal) substance used as
a raw material, which is coated on, bound to, or incorporated into the device to achieve an ancillary
device function (e.g. minimizing vascular restenosis)] in its final form for administration to the patient
(e.g. tablet, solution, spray), that is intended to prevent, diagnose, or treat disease and that achieves its
principal intended action in or on the body by pharmacological, immunological, or metabolic means
3.14
evaluate
qualitatively appraise or analyse
Note 1 to entry: Also see determine (3.7).
3.15
failure mode
difficulty or failure of the stent system that can be encountered (hazards) in preclinical in vivo or
clinical use of a vascular stent and could result in consequences (harm) to the subject
3.16
nominal diameter
primary labelled diameter of the stent
3.17
rated burst pressure
RBP
pressure at which a balloon would not be expected to burst based on appropriate confidence and
reliability
3.18
stent configuration
stent shape and geometry
Note 1 to entry: Examples include cylindrical, tapered, flared, coiled, segmented, bifurcated, articulated, closed
cell, open cell.
4 © ISO 2020 – All rights reserved

ISO 25539-2:2020(E)
3.19
stent outer surface area
maximum contact area between the stent and the vessel
Note 1 to entry: Although the entire stent may not contact the vessel wall depending on the conformance to the
vessel wall and the intended clinical use (e.g. for treatment of aneurysms), the stent outer surface area would
include the maximum potential area along the entire length of the stent.
3.20
stent-free surface area
percentage of surface area of cylinder formed by the implant frame, which is not covered by implant
material
3.21
stent system
vascular stent and its delivery system (3.6)
Note 1 to entry: If a stent is to be mounted on a delivery balloon, as specified in the instructions for use (IFU),
the balloon catheter is not considered part of the stent system with respect to the design requirements and
evaluation specified in this document, with the exception of the simulated use, in vivo animal, and clinical study
requirements. The balloon catheter would be part of the stent system for testing that evaluates the stent only
where the stent system is needed to conduct the testing.
3.22
vascular stent
vascular scaffold
stent
implant
transluminally placed balloon-expandable or self-expanding implant intended to maintain or restore
vessel patency or function
Note 1 to entry: Stents can have surface modifications, such as drug and/or other coatings.
Note 2 to entry: The requirements of this document include vascular stents and vascular scaffolds (e.g. absorbable
vascular scaffolds) and both are covered by the term stent for simplicity.
Note 3 to entry: The following stent types are within the scope of this document.
3.22.1
absorbable stent
stent that is designed to be a temporary structure without requiring explantation
3.22.2
articulated stent
stent constructed of segments with distinct connections
3.22.3
balloon-expandable stent
stent where the diameter is increased from its pre-deployed size to its deployed size with the aid of
a balloon
3.22.4
bare stent
stent without a coating or covering
Note 1 to entry: Bare stents can be constructed of a single or multiple materials.
Note 2 to entry: Bare stents can contain a metal oxide layer.
ISO 25539-2:2020(E)
3.22.5
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 of the bare stent [e.g. by covering the
stent-free surface area (3.20)]
Note 1 to entry: Stents containing only a metal oxide layer are not considered a coated stent for the purposes of
this document.
3.22.6
covered stent
stent covered with an additional material(s) that appreciably reduces permeability of the bare stent
[e.g. by covering the stent-free surface area (3.20)]
Note 1 to entry: 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 document.
3.22.7
drug-containing stent
stent that has a drug coating that is not intended to release the drug
Note 1 to entry: For the purposes of this document, drug-eluting refers to both drug-eluting and dr
...