Cardiovascular implants — Endovascular devices — Part 2: Vascular stents

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 non-viable biologic materials used in the construction of vascular stents.

Implants cardiovasculaires — Dispositifs endovasculaires — Partie 2: Endoprothèses vasculaires

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 vasculaire, tels que les dispositifs d'angioplastie par ballonnet, sont exclus du domaine d'application du présent document. Les dispositifs de pointage destinés à localiser les dissections post-angioplastie, les dispositifs de support de bobine et les dispositifs de diversion de flux sont couverts par le présent document, qui ne fournit cependant ni exigences, ni essais détaillés pour ces dispositifs. Bien que les stents à élution de médicaments entrent dans le domaine d'application du présent documen

General Information

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Publication Date
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Current Stage
6060 - International Standard published
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22-Sep-2020
Completion Date
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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
---------------------- Page: 1 ----------------------
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
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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
---------------------- Page: 4 ----------------------
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
---------------------- Page: 5 ----------------------
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
---------------------- Page: 6 ----------------------
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.

© ISO 2020 – All rights reserved vii
---------------------- Page: 7 ----------------------
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 2020 – All rights reserved 1
---------------------- Page: 8 ----------------------
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

cons
...

NORME ISO
INTERNATIONALE 25539-2
Troisième édition
2020-09
Implants cardiovasculaires —
Dispositifs endovasculaires —
Partie 2:
Endoprothèses vasculaires
Cardiovascular implants — Endovascular devices —
Part 2: Vascular stents
Numéro de référence
ISO 25539-2:2020(F)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 25539-2:2020(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2020

Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette

publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
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Publié en Suisse
ii © ISO 2020 – Tous droits réservés
---------------------- Page: 2 ----------------------
ISO 25539-2:2020(F)
Sommaire Page

Avant-propos ................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Domaine d'application ................................................................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 2

3 Termes et définitions ....................................................................................................................................................................................... 3

4 Exigences générales des ensembles stent/dispositif d'injection ......................................................................7

4.1 Généralités .................................................................................................................................................................................................. 7

4.2 Type de stent ............................................................................................................................................................................................ 7

4.3 Matériaux de construction de l'ensemble stent/dispositif d'injection .................................................. 7

4.4 Configuration et désignation de la taille des stents et ensembles stent/dispositif

d'injection .................................................................................................................................................................................................... 7

4.5 Définition de l'utilisation clinique prévue ....................................................................................................................... 7

4.6 Désignation du ballonnet ............................................................................................................................................................... 8

5 Performances attendues .............................................................................................................................................................................. 8

6 Caractéristiques de conception ............................................................................................................................................................. 8

6.1 Généralités .................................................................................................................................................................................................. 8

6.2 Ensemble stent/dispositif d'injection ................................................................................................................................. 9

6.3 Stent.................................................................................................................................................................................................................. 9

6.4 Stent et ensemble stent/dispositif d'injection............................................................................................................. 9

6.5 Revêtement du stent ou du système d'injection .....................................................................................................10

6.6 Revêtement du stent .......................................................................................................................................................................10

6.7 Stent ou revêtement absorbable ...........................................................................................................................................10

6.8 Stent à élution de médicaments ............................................................................................................................................10

7 Matériaux ..................................................................................................................................................................................................................11

8 Évaluation de la conception ...................................................................................................................................................................11

8.1 Généralités ...............................................................................................................................................................................................11

8.2 Échantillonnage ...................................................................................................................................................................................12

8.3 Préparation des échantillons d'essai ................................................................................................................................13

8.4 Établissement de rapports .........................................................................................................................................................13

8.5 Essais au banc et essais analytiques ..................................................................................................................................14

8.5.1 Ensemble stent/dispositif d'injection et système d'injection ................................................14

8.5.2 Stent .........................................................................................................................................................................................17

8.5.3 Stents absorbables et stents contenant un revêtement absorbable .................................24

8.5.4 Revêtement d'un système d'injection .........................................................................................................24

8.5.5 Revêtement d'un stent .............................................................................................................................................24

8.5.6 Stent médicamenteux ...............................................................................................................................................24

8.6 Évaluation préclinique in vivo ................................................................................................................................................25

8.6.1 Objet.........................................................................................................................................................................................25

8.6.2 Objectifs spécifiques ..................................................................................................................................................25

8.6.3 Considérations relatives au protocole ........................................................................................................26

8.6.4 Acquisition des données ........................................................................................................................................26

8.6.5 Rapport d'essai et information complémentaires ...........................................................................28

8.7 Évaluation clinique ...........................................................................................................................................................................29

8.7.1 Objet.........................................................................................................................................................................................29

8.7.2 Objectifs spécifiques ..................................................................................................................................................30

8.7.3 Considérations relatives au protocole ........................................................................................................30

8.7.4 Acquisition des données ........................................................................................................................................31

8.7.5 Rapport final .....................................................................................................................................................................34

9 Pharmacovigilance ..........................................................................................................................................................................................35

10 Fabrication ...............................................................................................................................................................................................................35

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ISO 25539-2:2020(F)

11 Stérilisation.............................................................................................................................................................................................................35

11.1 Produits fournis stériles ..............................................................................................................................................................35

11.2 Résidus de stérilisation.................................................................................................................................................................36

12 Emballage..................................................................................................................................................................................................................36

12.1 Généralités ...............................................................................................................................................................................................36

12.1.1 Généralités .........................................................................................................................................................................36

12.1.2 Conteneur unitaire ......................................................................................................................................................36

12.1.3 Conteneur externe .......................................................................................................................................................36

12.1.4 Unité d'expédition .......................................................................................................................................................36

12.1.5 Préservation de la stérilité durant le transport .................................................................................36

12.2 Étiquetage ................................................................................................................................................................................................36

12.2.1 Étiquetage du conteneur ........................................................................................................................................36

12.2.2 Stents sans système d'injection .......................................................................................................................36

12.2.3 Ensembles stent/dispositif d'injection (stents avec système d'injection) ..................37

12.2.4 Étiquette d'enregistrement .................. ................................................................................................................37

12.3 Notice d'informations du fabricant ....................................................................................................................................37

12.3.1 Généralités .........................................................................................................................................................................37

12.3.2 Informations et instructions pour l'utilisation des stents et/ou ensembles

stent/dispositif d'injection...................................................................................................................................38

Annexe A (informative) Relation entre les exigences d'essai, les caractéristiques

des dispositifs et les modes de défaillance potentiels, et recommandations pour

l'élaboration d'une stratégie d'évaluation du dispositif ..........................................................................................40

Annexe B (informative) Description des effets cliniques d'une défaillance .............................................................58

Annexe C (informative) Description des effets d'une défaillance sur le dispositif ............................................61

Annexe D (informative) Méthodes d'essai ...................................................................................................................................................63

Bibliographie .......................................................................................................................................................................................................................122

iv © ISO 2020 – Tous droits réservés
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ISO 25539-2:2020(F)
Avant-propos

L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes

nationaux de normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est

en général confiée aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l'ISO participent également aux travaux.

L'ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents

critères d'approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www

.iso .org/ directives).

L'attention est attirée sur le fait que certains des éléments du présent document peuvent faire l'objet de

droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l'élaboration du document sont indiqués dans l'Introduction et/ou dans la liste des déclarations de

brevets reçues par l'ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l'ISO liés à l'évaluation de la conformité, ou pour toute information au sujet de l'adhésion

de l'ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir le lien suivant: www .iso .org/ iso/ fr/ avant -propos.

Le présent document a été élaboré par le comité technique ISO/TC 150, Implants chirurgicaux, sous-

comité SC 2, Implants cardiovasculaires et circuits extra-corporels, en collaboration avec le Comité

européen de normalisation (CEN), comité technique CEN/TC 285, Implants chirurgicaux non actifs,

conformément à l'Accord de coopération technique entre l'ISO et le CEN (Accord de Vienne).

Cette troisième édition annule et remplace la deuxième édition (ISO 25539-2:2012), qui a fait l'objet

d'une révision technique.

Les principales modifications par rapport à l’édition précédente sont la mise à jour des essais et de

l'utilisation clinique des stents vasculaires ainsi que l'amélioration de la cohérence de la nomenclature

et des exigences relatives aux rapports.

Une liste de toutes les parties de la série ISO 25539 se trouve sur le site web de l'ISO.

Il convient que l'utilisateur adresse tout retour d'information ou toute question concernant le présent

document à l'organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l'adresse www .iso .org/ fr/ members .html.
© ISO 2020 – Tous droits réservés v
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ISO 25539-2:2020(F)
Introduction

Le présent document a été préparé pour fournir des exigences minimales destinées aux stents

vasculaires. Les raisons expliquant les exigences applicables aux essais au banc et analyses pour évaluer

la performance des dispositifs, les recommandations concernant l'identification des essais appropriés

pour évaluer une conception de dispositif spécifique et les recommandations concernant l'élaboration

des méthodes d'essai sont fournies dans les annexes informatives. Une clarification de la terminologie

est fournie dans des annexes informatives supplémentaires.

Le présent document a été mis à jour pour refléter les connaissances actuelles sur les essais et

l'utilisation clinique des stents vasculaires, pour représenter les modifications des exigences dans le

corps du document et dans les recommandations relatives au développement des méthodes d'essai de

l'Annexe D. En outre, des révisions ont été apportées pour améliorer la cohérence dans la nomenclature

et l'établissement des rapports ainsi que pour améliorer l'utilité du présent document.

Les exigences relatives à l'évaluation des caractéristiques spécifiques des stents (par exemple,

revêtements, élution de médicaments, absorption) sont incorporées par référence aux normes

concernées. Toutefois, tous les essais spécifiés dans les normes citées en référence ne s'appliquent

pas aux stents vasculaires. Seuls les essais portant sur les caractéristiques de conception spécifiées à

l'Article 6 sont exigés pour garantir la conformité au présent document.

Ce document révisé introduit une méthodologie permettant d'identifier les essais et analyses appropriés

pour un stent vasculaire spécifique, appelée stratégie d'évaluation du dispositif (SED). Les exigences

applicables à la stratégie d'évaluation du dispositif sont données dans le corps principal du document.

L'Annexe A fournit des recommandations pour le développement d'un tableau de stratégie d'évaluation

du dispositif de type ciblé, applicable spécifiquement aux caractéristiques uniques d'un dispositif,

aux modifications de conception du dispositif ou à l'évolution de son usage prévu. L'Annexe A fournit

également des recommandations pour l'élaboration d'un tableau de stratégie d'évaluation du dispositif

de type complet, pouvant être utilisé lorsqu'il apparaît insuffisant de se concentrer exclusivement sur

les caractéristiques uniques du dispositif ou sur ses modifications.

NOTE L'ISO 25539-1:2017 comprend des tableaux pouvant être utilisés pour justifier les essais nécessaires

en cas de modification de la conception du dispositif ou d'évolution de son usage prévu à l'Annexe A. Dans le

présent document, ce concept, appelé tableau de stratégie d'évaluation du dispositif de type ciblé, peut être

appliqué aussi bien à un nouveau dispositif qu'à un dispositif dont la conception ou l'usage prévu a été modifié.

Les autres modifications d'importance dans les exigences comprennent l'ajout d'un essai de durabilité

non radial, incluant des recommandations pour la sélection de l'essai approprié, et des exigences

spécifiques pour les essais évaluant les caractéristiques de perméabilité. Des recommandations

concernant l'élaboration d'essais appropriés permettant de respecter ces exigences sont incluses à

l'Annexe D.

Les recommandations concernant le développement de méthodes permettant de satisfaire aux

exigences lors de l'évaluation de la fatigue et de la durabilité à l'aide d'analyses informatiques ont

été modifiées de manière significative pour inclure des recommandations concernant la vérification

de la solution et la validation du modèle informatique, ainsi que l'établissement des rapports. Les

recommandations concernant le développement de modèles de simulation d'utilisation ont été révisées

de manière significative pour améliorer la pertinence clinique de cet essai.

Les exigences spécifiques pour l'évaluation de la poussabilité, de la flexibilité, de la capacité de torsion,

du cheminement et de la précision de déploiement d'un ensemble stent/dispositif d'injection ont été

retirées et intégrées aux exigences d'évaluation d'une simulation d'utilisation pour mieux représenter

la manière dont ces caractéristiques sont évaluées. De la même manière, l'exigence pour l'évaluation de

la résistance du tube à la traction a été retirée et intégrée à l'évaluation de la résistance à la traction des

liaisons.

Outre les modifications apportées aux exigences concernant l'évaluation des conceptions spécifiques,

des recommandations ont été fournies pour l'évaluation de l'acceptabilité des résultats d'essai. Lorsque

l'exigence consiste à estimer ou analyser quantitativement un paramètre, les résultats d'essai peuvent

vi © ISO 2020 – Tous droits réservés
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ISO 25539-2:2020(F)

généralement être comparés à une valeur quantitative (c'est-à-dire des critères d'acceptation). Pour les

essais de caractérisation, il est approprié de fournir une explication pour la pertinence des résultats. En

outre, certains essais peuvent inclure une comparaison des données d'essai ou des données existantes

issues de l'évaluation antérieure d'un dispositif.

Dans le cadre de l'évaluation de la conception, les exigences concernant l'échantillonnage, le

conditionnement des échantillons d'essai et l'établissement des rapports ont été intégrées au corps

du document. Les recommandations concernant ces éléments d'essai et la documentation figuraient

auparavant uniquement dans l'Annexe D.
Les titres des annexes du présent document ont été modifiés comme suit:
Annexe de l'ISO 25539-2:2012 Révision

Annexe A — Caractéristiques des dispositifs L'Annexe A établit désormais la relation entre les exigences

endovasculaires — Stents vasculaires — d'essai, les caractéristiques des dispositifs et les modes de

Considérations techniques et cliniques défaillance potentiels, et fournit des recommandations pour

l'élaboration d'une stratégie d'évaluation du dispositif.

Annexe B — Essais au banc et essais La liste des essais est incluse dans le Tableau D.1.

analytiques
L'Annexe B inclut maintenant une description des effets
cliniques potentiels de la défaillance. Elle présente également
les effets d'une défaillance des stents utilisés avec des
prothèses endovasculaires.

Annexe C — Définition des événements Le terme «événements cliniques à déclaration obligatoire» n'est

cliniques à déclaration obligatoire plus utilisé dans le présent document.
L'Annexe C inclut désormais une description des effets
potentiels d'une défaillance sur le dispositif. Elle présente
également les effets d'une défaillance des stents utilisés avec
des prothèses endovasculaires.

Annexe D — Méthodes d'essai La présente édition intègre les exemples d’équations, présentés

en complément de l'essai de durabilité à la fatigue sous charge
radiale à l'Annexe E de l'ISO 25539-2:2012, dans la présente
Annexe D.

Annexe E — Informations complémentaires L'Annexe E a été supprimée, étant donné que les exemples

sur l'approche analytique utilisée lors de d’équations présentés en complément de l'essai de durabilité à

l'essai de durabilité à la fatigue la fatigue sous charge radiale ont été incorporés à l'Annexe D.

Le présent comité de l'ISO reconnaît que de nombreux ensembles stent/dispositif d'injection se

sont révélés sûrs et efficaces pour une utilisation clinique. La présente mise à jour n'a pas vocation

à prescrire des évaluations supplémentaires sur ces dispositifs pour rester conforme au présent

document, puisque les essais ne devraient pas fournir d'informations utiles concernant la performance

clinique attendue du dispositif. Les fabricants peuvent s'appuyer sur les données historiques recueillies

selon les recommandations de la précédente édition de l'ISO 25539-2. De la même manière, en cas de

modifications sur le dispositif ou de changements relatifs à l'utilisation clinique prévue, la présente

mise à jour n'a pas vocation à prescrire des évaluations supplémentaires concernant les aspects du

dispositif non susceptibles de modifier la performance clinique.

NOTE L'Article A.1 décrit la relation entre les exigences d'essai, les caractéristiques des dispositifs et les

modes de défaillance potentiels. L'Article A.1 fournit également des informations générales sur les stratégies

d'évaluation du dispositif. Les Tableaux A.2 et A.3 fournissent les justifications des exigences spécifiées dans le

présent document et applicables aux essais au banc et aux analyses permettant d'évaluer les performances du

dispositif. Les titres des tableaux donnés en A.2 et A.3 sont explicités dans le Tableau A.1.

L'Article A.2 fournit des recommandations pour l'élaboration d'une stratégie d'évaluation spécifique au dispositif.

Deux approches sont proposées à cet égard: 1) une stratégie d'évaluation du dispositif de type ciblé, décrite en

A.2.1; et 2) une stratégie d'évaluation du dispositif de type complet, décrite en A.2.2.

L'Annexe B fournit une description des effets cliniques potentiels d'une défaillance identifiés à l'Annexe A.

L'Annexe C fournit une description des effets potentiels d'une défaillance sur le dispositif identifiés à l'Annexe A.

© ISO 2020 – Tous droits réservés vii
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ISO 25539-2:2020(F)

Des descriptions supplémentaires des effets cliniques et des effets sur le dispositif d'une défaillance sont incluses,

respectivement, aux Annexes B et C.

L'Annexe D fournit les informations à prendre en compte lors du développement des essais au banc et des

méthodes analytiques appropriés.
viii © ISO 2020 – Tous droits réservés
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NORME INTERNATIONALE ISO 25539-2:2020(F)
Implants cardiovasculaires — Dispositifs
endovasculaires —
Partie 2:
Endoprothèses vasculaires
1 Domaine d'application

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 configurati
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 25539-2
ISO/TC 150/SC 2
Cardiovascular implants —
Secretariat: ANSI
Endovascular devices —
Voting begins on:
2020-05-22
Part 2:
Voting terminates on:
Vascular stents
2020-07-17
Implants cardiovasculaires — Dispositifs endovasculaires —
Partie 2: Endoprothèses vasculaires
ISO/CEN PARALLEL PROCESSING
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 25539-2:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2020
---------------------- Page: 1 ----------------------
ISO/FDIS 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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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ISO/FDIS 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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ISO/FDIS 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 .........................................................................................................................................................................................................................114

iv © ISO 2020 – All rights reserved
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ISO/FDIS 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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ISO/FDIS 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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ISO/FDIS 25539-2:2020(E)
The revisions to the titles of the annexes to this document are as follows:
Annex of ISO 25593-2:2012 Revision

Annex A — 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 the 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.

© ISO 2020 – All rights reserved vii
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 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 2020 – All rights reserved 1
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ISO/FDIS 25539-2:2020(E)
Although absorbable stents and stents with absorbable coatings are within the s
...

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