Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO 25539-2:2020)

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.
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 nonviable
biologic materials used in the construction of vascular stents.

Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: Gefäßstents (ISO 25539-2:2020)

In diesem Dokument sind Anforderungen an die Bewertung von Stentsystemen (Gefäßstents und Einführsysteme) sowie Anforderungen bezüglich der Nomenklatur, der Konstruktionsmerkmale und der vom Hersteller bereitgestellten Informationen auf der Grundlage des derzeitigen medizinischen Wissensstandes festgelegt. Eine Leitlinie für die Entwicklung von In vitro Prüfverfahren findet sich in Anhang D. Dieses Dokument ist eine Ergänzung zu ISO 14630, die allgemeine Anforderungen an die Funktion nichtaktiver chirurgischer Implantate festlegt.
ANMERKUNG 1   Aufgrund der Variationen in der Konstruktion der von diesem Dokument abgedeckten Implantate sowie in einigen Fällen aufgrund des Aufkommens neuer Typen solcher Implantate 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 Dokuments notwendig.
Dieses Dokument bezieht sich auf Gefäßstents und Gefäßgerüste (z. B. absorbierbare Gefäßgerüste), die zur Behandlung vaskulärer Stenosen oder sonstiger vaskulärer Anomalien oder Erkrankungen eingesetzt werden. Einige der Anforderungen gelten spezifisch für die endovaskuläre Behandlung arterieller Stenosen. Die Verwendung von Stentsystemen über die Behandlung arterieller Stenosen (z. B. Venen-Stenting) hinaus fällt zwar in den Anwendungsbereich dieses Dokuments, jedoch werden für diese Anwendungen keine umfassenden Anforderungen und Prüfungen beschrieben. Ebenso fallen bestimmte Stentkonfigurationen (z. B. Bifurkationsstents) in den Anwendungsbereich dieser Norm, jedoch werden für diese Implantate keine umfassenden Anforderungen und Prüfungen beschrieben.
Stents, die in Kombination mit einer endovaskulären Prothese verwendet werden, um die Behandlung einer Läsion zu vervollständigen, darunter überbrückende Stents (z. B. Stents, die nach Einführen einer fenestrierten endovaskulären Prothese in die Nierenarterien platziert werden), fallen in den Anwendungsbereich dieses Dokuments, Prüfverfahren werden für die Kombination jedoch nicht beschrieben. ISO 25539 1 enthält Informationen für vorklinische In vivo  und klinische Bewertungen solcher Stents.
Gefäßstents mit Oberflächenmodifikationen, wie zum Beispiel Arzneimittel  und/oder andere Beschichtungen, fallen in den Anwendungsbereich dieses Dokuments. Stents, die mit Materialien ummantelt sind, die die Durchlässigkeit des nicht ummantelten Stents signifikant verändern (z. B. indem sie die stentfreie Oberfläche bedecken), liegen im Anwendungsbereich von ISO 25539 1. Die Konstruktion oder der vorgesehene Verwendungszweck des Stents könnte die Anwendung funktionaler Anforderungen sowohl der ISO 25539 1 als auch dieses Dokuments erforderlich machen (z. B. Stents, die in Kombination mit endovaskulären Prothesen verwendet werden, Stents, die zur Behandlung von Aortenaneurysmen verwendet werden).
[...]

Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Endoprothèses vasculaires (ISO 25539-2:2020)

Le présent document spécifie les exigences relatives à l'évaluation des ensembles stent/dispositif d'injection (stents vasculaires et systèmes d'injection) et les exigences relatives à la nomenclature, aux caractéristiques de conception et aux informations fournies par le fabricant, sur la base des connaissances médicales actuelles. Les recommandations relatives à l'élaboration des méthodes d'essai in vitro figurent à l'Annexe D. Le présent document complète l'ISO 14630, qui spécifie les exigences générales relatives aux performances des implants chirurgicaux non actifs.
NOTE 1 En raison des variantes de conception parmi les implants traités dans le présent document et en raison, dans certains cas, de l'émergence de nouveaux types de tels implants, des essais in vitro normalisés et des résultats cliniques acceptables ne sont pas toujours disponibles. Lorsque de nouvelles données scientifiques et cliniques seront disponibles, il sera nécessaire de procéder à une révision appropriée du présent document.
Le présent document s'applique aux stents vasculaires et aux supports vasculaires (par exemple, supports vasculaires absorbables) utilisés pour le traitement des sténoses vasculaires ou d'autres troubles ou pathologies vasculaires. Certaines des exigences sont spécifiques au traitement endovasculaire des sténoses artérielles. Bien que les utilisations d'ensembles stent/dispositif d'injection autres que le traitement des sténoses artérielles (par exemple, implantation de stents veineux) entrent dans le domaine d'application du présent document, les exigences et essais complets ne sont pas décrits pour de telles utilisations. De la même manière, les configurations de stents spécifiques (par exemple, stents de bifurcation) entrent dans le domaine d'application du présent document, mais les exigences et essais complets ne sont pas décrits pour ces dispositifs.
Les stents utilisés en combinaison avec une prothèse endovasculaire afin de compléter le traitement d'une lésion, y compris les stents de pontage (par exemple, stents placés dans les artères rénales après la pose d'une prothèse endovasculaire fenêtrée), entrent dans le domaine d'application du présent document, mais les méthodes d'essai ne sont pas décrites pour l'ensemble combiné. L'ISO 25539-1 fournit également des informations pertinentes pour les évaluations précliniques in vivo et les évaluations cliniques de ces stents.
Les stents vasculaires modifiés en surface, avec par exemple un enrobage médicamenteux et/ou d'autres formes de revêtements, sont couverts par le présent document. Les stents recouverts de matériaux qui modifient sensiblement l'étanchéité du stent nu (par exemple, en recouvrant la surface du vaisseau sans contact avec le stent) sont compris dans le domaine d'application de l'ISO 25539-1. La conception ou l'utilisation prévue du stent peut imposer la nécessité de prendre en compte les exigences fonctionnelles identifiées dans l'ISO 25539-1 et dans le présent document (par exemple, dans le cas de stents utilisés conjointement avec des prothèses endovasculaires ou de stents utilisés pour le traitement d'anévrismes aortiques).
Les ballonnets intégrés à l'ensemble stent/dispositif d'injection sont couverts par le présent document. Le présent document fournit des exigences allant au-delà de celles de l'ISO 10555-4, spécifiques à l'utilisation de ballonnets avec des stents vasculaires.
Les techniques et les dispositifs utilisés avant l'introduction du stent vasculair

Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 2. del: Žilne opornice (stent) (ISO 25539-2:2020)

General Information

Status
Published
Public Enquiry End Date
19-Jul-2019
Publication Date
19-Oct-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
08-Oct-2020
Due Date
13-Dec-2020
Completion Date
20-Oct-2020

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SLOVENSKI STANDARD
SIST EN ISO 25539-2:2020
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
SIST EN ISO 25539-2:2020 en

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

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SIST EN ISO 25539-2:2020
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SIST EN ISO 25539-2:2020
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.
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SIST EN ISO 25539-2:2020
EN ISO 25539-2:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

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SIST EN ISO 25539-2:2020
EN ISO 25539-2:2020 (E)
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.
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SIST EN ISO 25539-2:2020
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SIST EN ISO 25539-2:2020
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
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SIST EN ISO 25539-2:2020
ISO 25539-2:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© 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

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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SIST EN ISO 25539-2:2020
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 2020 – All rights reserved iii
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SIST EN ISO 25539-2:2020
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
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SIST EN ISO 25539-2:2020
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 2020 – All rights reserved v
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SIST EN ISO 25539-2:2020
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
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SIST EN ISO 25539-2:2020
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 pro
...

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