oSIST prEN ISO 25539-2:2019

SLOVENSKI STANDARD
oSIST prEN ISO 25539-2:2019
01-julij-2019

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

Cardiovascular implants - Endovascular devices - Part 2: Vascular stents (ISO/DIS

Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 2: GefäÃstents (ISO

Implants cardiovasculaires - Dispositifs endovasculaires - Partie 2: Endoprothèses

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

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

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 Type of stent .............................................................................................................................................................................................. 6

4.2 Materials of construction for stent system ..................................................................................................................... 6

4.3 Configuration and size designation for stents and stent systems ............................................................... 6

4.4 Intended clinical use designation ........................................................................................................................................... 6

4.5 Balloon designation ............................................................................................................................................................................ 7

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 ..................................................................................................................................................................... 8

6.5 Coating on delivery system or stent ..................................................................................................................................... 9

6.6 Absorbable stent or coating ......................................................................................................................................................... 9

6.7 Drug-eluting stent ................................................................................................................................................................................ 9

7 Materials ....................................................................................................................................................................................................................10

8 Design evaluation .............................................................................................................................................................................................10

8.1 General ........................................................................................................................................................................................................10

8.2 Sampling ....................................................................................................................................................................................................11

8.3 Conditioning of test samples ....................................................................................................................................................11

8.4 Reporting ..................................................................................................................................................................................................12

8.5 Bench and analytical tests ..........................................................................................................................................................13

8.5.1 Stent system and delivery system ..................................................................................................................13

8.5.2 Stent .........................................................................................................................................................................................15

8.5.3 Absorbable stents and stents containing an absorbable coating ........................................21

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 ..................................................................................................................................................22

8.6.1 Purpose .................................................................................................................................................................................22

8.6.2 Specific aims .....................................................................................................................................................................23

8.6.3 Protocol considerations ..........................................................................................................................................23

8.6.4 Data acquisition .............................................................................................................................................................24

8.6.5 Test report and additional information ....................................................................................................25

8.7 Clinical evaluation .............................................................................................................................................................................26

8.7.1 Purpose .................................................................................................................................................................................26

8.7.2 Specific aims .....................................................................................................................................................................27

8.7.3 Protocol considerations ..........................................................................................................................................27

8.7.4 Data acquisition .............................................................................................................................................................28

8.7.5 Final report ........................................................................................................................................................................31

9 Post-market surveillance ..........................................................................................................................................................................32

10 Manufacturing ......................................................................................................................................................................................................32

11 Sterilization ............................................................................................................................................................................................................32

11.1 Products supplied sterile ............................................................................................................................................................32

11.2 Sterilization residuals ....................................................................................................................................................................32

12 Packaging ..................................................................................................................................................................................................................32

12.1 Protection from damage in storage and transport................................................................................................32

12.1.1 General...................................................................................................................................................................................32

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 .........................34

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 ............................................................................................52

Annex C (informative) Description of device effects of failure ...............................................................................................55

Annex D (informative) Test methods ................................................................................................................................................................57

Bibliography .........................................................................................................................................................................................................................113

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

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International

Standards adopted by the technical committees are circulated to the member bodies for voting.

Publication as an International Standard requires approval by at least 75 % of the member bodies

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO 25539-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee

ISO 25539 consists of the following parts, under the general title Cardiovascular implants — Endovascular

This part of ISO 25539 was prepared to provide minimum requirements for vascular stents. The

normative requirements are provided in the main body. 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.

The standard 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

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

requirements in these standards are relevant to vascular stents. Information regarding applicability of

these standards to specific types of stents (e.g. coated) are clarified by the definitions in Clause 3 of this

standard. For example, the definition of a coated stent excludes stents with an oxide layer and therefore

the requirements of ISO 17327-1 Non-active surgical implants — Implant coating —Part 1:General

requirements are not applicable to stents with only an oxide layer. In addition, not all tests listed in the

respective standards are applicable to vascular stents. Only tests that address the design attributes

The revised standard 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

NOTE The revision of Part 1: Endovascular prostheses includes tables that may be used to justify the

testing needed for device design modifications and changes in intended use in Annex A. In Part 2, this concept

is called a focused device evaluation strategy table and may be applied to a new device as well as device design

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

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

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

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

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

A Attributes of endovascular devices — Vascular Annex A now includes the relationship between

stents — Technical and clinical considerations testing requirements, device attributes, and

C Definitions of reportable clinical events The term reportable clinical events is no longer

E Sample equations as a supplement to the radial There is no Annex E as this information was

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 standard 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 version 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

Part 2 of ISO 25539 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 an informative annex to this standard. This standard should be

considered as a supplement to ISO 14630, which specifies general requirements for the performance of

NOTE Due to the variations in the design of implants covered by this part of ISO 25539 and in some cases

due to the relatively recent development of some of these implants (e.g. absorbable stents, polymeric stents),

acceptable standardized in vitro tests and clinical results are not always available. As further scientific and

clinical data become available, appropriate revision of this part of ISO 25539 will be necessary.

The scope of this part of ISO 25539 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

standard, 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

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 standard, but test methods are not described for

the combination. The preclinical in vivo and clinical evaluations of these stents may be addressed with

the evaluations of the associated endovascular prosthesis in accordance with ISO 25539-1.

Vascular stents that have surface modifications, such as drug and/or other coatings, are within the

scope of this standard. 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 part of ISO 25539 (e.g. stents used in combination with endovascular

Balloons integral to the stent system are within the scope of this standard. This part of ISO 25539

provides requirements beyond the requirements of ISO 10555-4 Intravascular catheters — Sterile and

This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of the

Tacking devices intended to spot treat post-angioplasy dissections, coil supporting devices, and flow

diverters are within the scope of this standard, but comprehensive requirements and testing are not

Although drug-eluting stents are within the scope of this standard, this standard is not comprehensive

NOTE Vascular device-drug combination products are within the scope of ISO 12417-1 Cardiovascular

Although absorbable stents and stents with absorbable coatings are within the scope of this standard,

this standard in not comprehensive with respect to the absorbable properties of these devices.

NOTE Absorbable implants are within the scope of ISO/TS 17137 Cardiovascular implants and extracorporeal

Although coated stents and coated stent systems are within the scope of this stan