EN ISO 25539-1:2009

SLOVENSKI STANDARD
01-julij-2009
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Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO
25539-1:2003 including Amd 1:2005)
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 1: Endovaskuläre
Prothesen (ISO 25539-1:2003, einschließlich Amd 1:2005)
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothèses
endovasculaires (ISO 25539-1:2003, Amd 1:2005 inclus)
Ta slovenski standard je istoveten z: EN ISO 25539-1:2009
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 25539-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2009
ICS 11.040.40 Supersedes EN ISO 25539-1:2008
English Version
Cardiovascular implants - Endovascular devices - Part 1:
Endovascular prostheses (ISO 25539-1:2003 including Amd
1:2005)
Implants cardiovasculaires - Dispositifs endovasculaires - Kardiovaskuläre Implantate - Endovaskuläre Implantate -
Partie 1: Prothèses endovasculaires (ISO 25539-1:2003, Teil 1: Endovaskuläre Prothesen (ISO 25539-1:2003,
Amd 1:2005 inclus) einschließlich Amd 1:2005)
This European Standard was approved by CEN on 19 April 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 25539-1:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

Foreword
The text of ISO 25539-1:2003, including Amd 1:2005 has been prepared by Technical Committee ISO/TC 150
“Implants for surgery” of the International Organization for Standardization (ISO) and has been taken over as
which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 25539-1:2008.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive.
For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 25539-1:2003, including Amd 1:2005 has been approved by CEN as a EN ISO 25539-1:2009
without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in table ZA confers, within the limits of the scope of this standard, a presumption of conformity
with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN Directive 93/42/EEC
4 1 - 2 -3 - 4 - 7.1
5 1 - 2 - 3 - 4 - 5 - 7.1 - 7.2 - 7.3 -
7.5 - 7.6 - 8 - 9.1 - 9.2
6 1 - 2 - 7.1 - 7.2 - 7.3 - 7.4 - 7.5 - ER 7.4 includes a mandatory
7.6 - 8.2 - 9.2 consultation of regulatory
authorities in relation to
medicinal substances that is not
addressed in this European
Standard.
7 1 - 2 - 3 - 4 - 6 - 6a. - 7.1 - 7.2 -
7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2
8 1 - 2 - 3 - 5 - 7.1 - 7.2
9 1 - 2 - 7.2 - 8.1 - 8.2 - 8.3 - 8.4
10.1 1 - 2 - 3 - 5 - 7.2 - 7.3 - 7.4 - 7.6 - ER 7.4 includes a mandatory
8.3 - 8.4 consultation of regulatory
authorities in relation to
medicinal substances that is not
addressed in this European
Standard.
10.2 - 10.3 1 - 2 - 8.7 - 9.1 - 13 The part of ER 13.3.a
concerning the information of the
authorized representative is not
addressed in this European
Standard.
Part of ER 13.3 f relating to
single use is not addressed in
this European Standard.
Part of ER 13.6 h) relating to
single use is not addressed in
this European Standard.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
INTERNATIONAL ISO
STANDARD 25539-1
First edition
2003-03-01
Cardiovascular implants — Endovascular
devices —
Part 1:
Endovascular prostheses
Implants cardiovasculaires — Dispositifs endovasculaires —
Partie 1: Prothèses endovasculaires

Reference number
ISO 25539-1:2003(E)
©
ISO 2003
ISO 25539-1:2003(E)
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ii © ISO 2003 — All rights reserved

ISO 25539-1:2003(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 Intended performance. 3
5 Design attributes. 3
5.1 General. 3
5.2 Delivery system. 4
5.3 Implant. 4
6 Materials. 4
7 Design evaluation. 5
7.1 General. 5
7.2 Delivery (and/or endovascular) system . 5
7.3 Implant. 11
7.4 Preclinical in vivo evaluation. 19
7.5 Clinical evaluation. 22
8 Manufacturing. 25
9 Sterilization. 25
9.1 Products supplied sterile. 25
9.2 Products supplied non-sterile. 26
9.3 Sterilization residuals. 26
10 Packaging. 26
10.1 Protection from damage in storage and transport . 26
10.2 Marking. 27
10.3 Information supplied by the manufacturer. 27
Annex A (informative) Attributes of endovascular devices— Technical and clinical considerations. 29
Annex B (informative) Bench and analytical tests . 36
Annex C (informative) Definitions of reportable clinical events. 39
Bibliography . 42

ISO 25539-1:2003(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
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 25539-1 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,
Cardiovascular implants.
ISO 25539 consists of the following parts, under the general title Cardiovascular implants — Endovascular
devices:
 Part 1: Endovascular prostheses
 Part 2: Vascular stents
 Part 3: Vena cava filters
iv © ISO 2003 — All rights reserved

ISO 25539-1:2003(E)
Introduction
This part of ISO 25539 has been prepared in order to provide minimum requirements for endovascular
prostheses and the methods of test that will enable their evaluation. It is the first part of a proposed three-part
International Standard. ISO/TS 15539, from which this part of ISO 25539 is derived, serves as a rationale for
the requirements. The Technical Specification was developed by first identifying the design requirements for
endovascular implants and listing the potential implant and clinical failure modes. Tests were then identified to
address each of the failure modes. The requirements provided in this part of ISO 25539 are based on that
assessment.
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, 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 undertaken.

INTERNATIONAL STANDARD ISO 25539-1:2003(E)

Cardiovascular implants — Endovascular devices —
Part 1:
Endovascular prostheses
1 Scope
1.1 This part of ISO 25539 specifies requirements for endovascular prostheses, based upon current
medical knowledge. With regard to safety, it gives requirements for intended performance, design attributes,
materials, design evaluation, manufacturing, sterilization packaging and information supplied by the
manufacturer. It should be considered as a supplement to ISO 14630, which specifies general requirements
for the performance of non-active surgical implants.
1.2 This part of ISO 25539 is applicable to endovascular prostheses used to treat arterial aneurysms,
arterial stenoses, or other appropriate vascular abnormalities.
1.3 This part of ISO 25539 is applicable to delivery systems if they comprise an integral component of the
deployment of the endovascular prostheses.
1.4 This part of ISO 25539 is not applicable to vascular occluders, with the exception of contra-lateral iliac
occluders when used as an integral part of an aorto-uni-iliac device. See ISO 14630 for excluded products.
1.5 This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of the
endovascular system (defined in 3.6), such as balloon angioplasty devices.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 7198:1998, Cardiovascular implants — Tubular vascular prostheses
ISO 11134:1994, Sterilization of health care products — Requirements for validation and routine control —
Industrial moist heat sterilization
ISO 11135:1994, Medical devices — Validation and routine control of ethylene oxide sterilization
ISO 11137:1995, Sterilization of health care products — Requirements for validation and routine control —
Radiation sterilization
ISO 10993 (all parts), Biological evaluation of medical devices
ISO 11607:1997, Packaging for terminally sterilized medical devices
ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 13488:1996, Quality systems — Medical devices — Particular requirements for the application of
ISO 9002
ISO 14155 (all parts), Clinical investigation of medical devices for human subjects
ISO 25539-1:2003(E)
ISO 14160, Sterilization of single-use medical devices incorporating materials of animal origin — Validation
and routine control of sterilization by liquid chemical sterilants
ISO 14630:1997, Non-active surgical implants — General requirements
ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing
agent and the development, validation and routine control of a sterilization process for medical devices
ISO 14971:2000, Medical devices -— Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7198 and ISO 14630 and the
following apply.
3.1
attachment system
system integral to the endovascular prosthesis that is designed to interface directly with vessel wall in order to
prevent migration
NOTE The system may also prevent blood flow on the outside of the prostheses at the attachment sites.
3.2
delivery system
system or mechanism used to deliver the endovascular prosthesis to the targeted position
NOTE The delivery system is removed after implant placement.
3.3
determine
quantitatively appraise or analyse
3.4
endoleak
persistence of blood flow outside the lumen of an endovascular prosthesis but within an aneurysm sac or
adjacent vascular segment being treated by the graft
NOTE Endoleaks are catagorized as follows:
 a Type I endoleak is periprosthetic and occurs at the proximal or distal attachment zone;
 a Type II endoleak is caused by retrograde flow from patent branch arteries, for example lumbar and intercostal;
 a Type III endoleak arises from a defect in the graft material or from an inadequate seal between modular graft
components;
 a Type IV endoleak is due to graft permeability, often identified by a generalized blush of contrast within the
aneurysm sac.
3.5
endovascular prosthesis
endovascular graft
endovascular implant
transluminally placed vascular prosthesis, residing partially or completely within a vascular conduit to form an
internal bypass or shunt between sections of the vascular system
2 © ISO 2003 — All rights reserved

ISO 25539-1:2003(E)
3.6
endovascular system
system used to treat a vascular lesion from within the vessel, typically comprised of an endovascular
prosthesis and its delivery system
NOTE 1 An abdominal aortic aneurysm is an example of a vascular lesion which can be treated with an endovascular
system.
NOTE 2 For the purposes of this part of ISO 25539, the delivery system as well as the implant are included within this
definition.
3.7
evaluate
qualitatively appraise or analyse
3.8
graft material
non-metallic component of the endovascular prosthesis
3.9
reportable clinical events
complications or failures that may be observed with clinical use of the endovascular system
4 Intended performance
The requirements of Clause 4 of ISO 14630:1997 shall apply.
5 Design attributes
5.1 General
The requirements of Clause 5 of ISO 14630:1997 shall apply. In addition, the following shall be taken into
account:
a) with regard to oxidation potential: the possibility of crevice corrosion passivation level over the relevant
parts;
b) with regard to wear: fretting corrosion;
c) with regard to interface between implant and body:
1) fixation hooks if present;
2) relative movement between implant and tissue;
3) forces exerted by the device on the surrounding tissue;
4) forces required to deform the implant if the deformation is permanent;
d) expected ingrowth, penetration, perforation, tilting and migration;
e) introduction and delivery systems.
NOTE These additional items are adapted from Clause 5 of EN 12006-3:1998.
ISO 25539-1:2003(E)
5.2 Delivery system
The design attributes to meet the intended performance of the delivery system shall additionally take into
account at least the following:
a) the ability of the system to permit consistent, accurate and safe access to the intended location;
b) the ability of the system to permit consistent, accurate and safe deployment of the implant;
c) the ability of the system to permit consistent and safe withdrawal of the delivery system;
d) the compliance of the system with the requirements of ISO 10993-1 and appropriate other parts of the
ISO 10993 series;
e) the ability of the system to minimize blood loss (haemostasis);
f) the visibility of the system under fluoroscopy or other technologies.
5.3 Implant
The design attributes to meet the intended performance of the implant shall additionally take into account at
least the following:
a) the ability of the implant to be consistently, accurately and safely deployed;
b) the ability of the implant to ensure effective fixation within the vasculature;
c) the ability of the implant to maintain adequate integrity;
d) the ability of the implant to prevent blood from flowing through the implant wall as appropriate to its
intended use;
Changes in wall permeability after implantation shall be taken into account.
e) the appropriate interaction between and among the modules of endovascular systems designed with
modular components (modularity);
f) the consistency of the implant dimensions and its design for compatibility for use in specified vessel
diameters;
g) the ability of the implant to maintain adequate blood flow through the lumen (patency);
h) the compatibility of the implant with exposure to magnetic resonance imaging (MRI) fields;
i) the compliance of the implant with the requirements of ISO 10993-1 and appropriate other parts of the
ISO 10993 series;
j) the visibility of the implant under fluoroscopy or other technologies.
6 Materials
The requirements of Clause 6 of ISO 14630:1997 shall apply. Additional testing specific to certain materials
should be performed to determine the appropriateness of the material for use in the design. For example,
Nitinol materials dependent on shape-memory properties should be subjected to testing in order to assess
transformation properties.
4 © ISO 2003 — All rights reserved

ISO 25539-1:2003(E)
7 Design evaluation
7.1 General
The requirements of Clause 7 of ISO 14630:1997 shall apply. A risk analysis shall be carried out in
accordance with the requirements of ISO 14971.
NOTE All testing may not be appropriate for all prosthesis designs.
Justification shall be provided for the properties not measured for characterization.
It is impossible to take into consideration all future and emerging technologies. These emerging-technology
prostheses will need to follow the basic test protocols of this part of ISO 25539 to characterize the
endovascular system. Testing beyond the scope of this part of ISO 25539 may also be necessary to
characterize new emerging-technology prostheses. Consideration shall be given to the failure modes of the
prostheses and their effects on the performance of the implant in identifying the appropriate testing. For
compound prostheses, as defined in ISO 7198:1998, 3.9, although it may be appropriate to conduct some of
the testing described in this part of ISO 25539 on components of the prosthesis, testing of the endovascular
system as a whole is also required. In addition, if the compound prosthesis is partially constructed of a
resorbable component, the non-resorbable portion of the implant shall be characterized as well as the implant
as a whole.
Each segment of a composite prosthesis, as defined in ISO 7198:1998, 3.8, shall be tested. In addition, any
manufactured anastomosis shall satisfy the requirements of this part of ISO 25539 relating to leakage and
factory anastomotic strength.
Retesting shall be performed whenever significant changes are made in materials, construction, configuration,
application, or processing methods.
A complete description of the validated test methods and sample preparation procedures used to address the
requirements of this part of ISO 25539 shall be documented by the manufacturer. The method and sample
size chosen shall be justified. Where acceptance criteria are not specified, the manufacturer shall evaluate the
acceptability of the results against predetermined criteria.
For certain design attributes, the use of a reference device should be considered.
If it can be justified that sterilization has no effect on the characteristics of the device that are under evaluation,
the required tests may be carried out on non-sterilized devices.
7.2 Delivery (and/or endovascular) system
7.2.1 Ability to access
7.2.1.1 General
The ability of the system to permit safe, consistent and accurate access to the intended location shall be
evaluated.
Hazards to be evaluated include, but are not limited to, the following:
a) guidewire not crossing the lesion;
b) introducer and delivery systems not matching the access site (i.e. size mismatch);
c) delivery system not advancing to target site;
d) emboli generation;
e) implant dislodgement.
ISO 25539-1:2003(E)
These hazards can result in the following reportable clinical events, including but not limited to the following:
 access failure;
 vascular trauma;
 neurological deficit;
 ischaemia;
 spinal neurological deficit;
 embolization.
Testing shall include the following items listed in 7.2.1.2 through 7.2.1.12, as appropriate to the design of the
endovascular system.
7.2.1.2 Bond strength
Determine the longitudinal bond strength between parts of the delivery system. All bonds shall remain intact
under recommended conditions of use. The results shall be evaluated in relation to the force(s) necessary to
access, deploy and withdraw the system.
7.2.1.3 Component dimension compatibility
Determine the dimensions of the endovascular system for compatibility with the dimensions of recommended
accessories. All components shall be dimensionally compatible.
7.2.1.4 Dimensional verification
Determine the appropriate dimensions for conformance with design specifications.
7.2.1.5 Flex/kink
Evaluate the ability of the endovascular system to bend in order to accommodate the minimum radius or angle
to be negotiated during access and delivery.
7.2.1.6 Profile
Determine the maximum diameter along defined sections of the endovascular system.
7.2.1.7 Pushability
Evaluate the ability of the endovascular system to be pushed or positioned by an operator without bending or
buckling.
7.2.1.8 Visibility
Evaluate the ability to visualize the delivery system during access using fluoroscopy. The use of other
technologies shall be justified.
7.2.1.9 Simulated use
Evaluate the performance of the delivery system using a model that simulates the intended use conditions.
7.2.1.10 Torquability
Evaluate the ability of the endovascular system to provide sufficient rotation to the distal (leading) end to
deliver the implant within the anatomy in accordance with the design constraints of the system.
6 © ISO 2003 — All rights reserved

ISO 25539-1:2003(E)
7.2.1.11 Torsional bond strength
Determine the torque required to break joints and/or materials in the appropriate delivery system components.
The results shall be evaluated in relation to the force(s) necessary to access, deploy and withdraw the system.
7.2.1.12 Trackability
Evaluate the ability of the endovascular system to advance over the recommended guidewire and to follow the
guidewire tip along the path of the vessel, including in narrow, tortuous vessels.
7.2.2 Ability to deploy
7.2.2.1 General
The ability of the system to permit safe, consistent and accurate deployment of the implant shall be evaluated.
Hazards to be evaluated include, but are not limited to, the following:
a) inability to fully and properly deploy the prosthesis;
b) disproportionate dimensions and properties, such as balloon compliance and burst pressure, of balloon
relative to endovascular system and vessel (if applicable);
c) implant dislodgement;
d) balloon failure (if applicable);
e) damage of implant components by other components;
f) inadequate visualization;
g) emboli generation.
These hazards can result in the following reportable clinical events, including but not limited to the following:
 delivery system failure;
 spinal neurological deficit;
 neurological deficit;
 vascular trauma;
 ischaemia;
 embolization;
 damage to implant.
Testing shall include the following items listed in 7.2.2.2 through 7.2.2.14, as appropriate to the design of the
endovascular system.
7.2.2.2 Bond strength
Determine the longitudinal bond strength between parts of the delivery system. All bonds shall remain intact
under recommended conditions of use.
ISO 25539-1:2003(E)
7.2.2.3 Balloon inflation time
Determine the time required to expand the balloon to the maximum recommended inflation pressure.
7.2.2.4 Balloon deflation time
Determine the time required to deflate the balloon and characterize the ability to remove the deflated balloon.
7.2.2.5 Balloon mean burst pressure
Determine the mean burst pressure.
7.2.2.6 Balloon rated burst pressure
Determine the burst pressure with an appropriate safety margin including reliability parameters.
Designate the maximum recommended inflation pressure and operating pressure(s).
7.2.2.7 Balloon rated fatigue
Determine the maximum number of recommended inflation cycles to the recommended inflation pressure
including reliability parameters.
Designate the maximum recommended number of inflation cycles.
7.2.2.8 Component dimension compatibility
Determine the dimensions of the endovascular system for compatibility with the dimensions of recommended
accessories. All components shall be dimensionally compatible.
7.2.2.9 Dimensional verification
Determine the appropriate dimensions for conformance with design specifications.
7.2.2.10 Force to deploy
Determine the force to deploy the implant.
7.2.2.11 Visibility
Evaluate the ability to visualize the implant and delivery system during placement and deployment using
fluoroscopy. The use of other technologies shall be justified.
7.2.2.12 Simulated use
Evaluate the performance of the endovascular system using a model that simulates the intended use
conditions.
7.2.2.13 Torsional bond strength
Determine the torque required to break joints and/or materials in the appropriate delivery system components.
7.2.2.14 Tubing tensile strength
Determine the strength of the tubing used in the delivery system as appropriate to the material.
8 © ISO 2003 — All rights reserved

ISO 25539-1:2003(E)
7.2.3 Ability to withdraw
7.2.3.1 General
The ability of the system to permit safe and consistent withdrawal of the delivery system shall be evaluated.
Hazards to be evaluated include, but are not limited to, the following.
a) improper balloon deflation (balloon expandable);
b) balloon winging (balloon expandable);
c) lack of structural integrity;
d) emboli generation;
e) diameter mismatch;
f) implant dislodgement;
g) damage of endovascular system components by other components;
h) delivery system snags on the implant;
i) inadequate visualization.
These hazards can result in the following reportable clinical events, including but not limited to the following:
 delivery system failure;
 neurological deficit;
 vascular trauma;
 ischaemia;
 spinal neurological deficit;
 embolization;
 damage to implant.
Testing shall include the following items in 7.2.3.2 through 7.2.3.9, as appropriate to the design of the
endovascular system.
7.2.3.2 Bond strength
Determine the longitudinal bond strength between parts of the delivery system. All bonds shall remain intact
under recommended conditions of use.
7.2.3.3 Component dimension compatibility
Determine the dimensions of the endovascular system for compatibility with the dimensions of recommended
accessories. All components shall be dimensionally compatible.
7.2.3.4 Dimensional verification
Determine the appropriate dimensions for conformance with design specifications.
ISO 25539-1:2003(E)
7.2.3.5 Flex/kink
Evaluate the ability of the delivery system to bend in order to accommodate the minimum radius or angle to be
negotiated during withdrawal.
7.2.3.6 Visibility
Evaluate the ability to visualize the endovascular system during withdrawal using fluoroscopy. The use of
other technologies shall be justified.
7.2.3.7 Simulated use
Evaluate the performance of the endovascular system using a model that simulates the intended use
conditions.
7.2.3.8 Torsional bond strength
Determine the torque required to break joints and/or materials in the appropriate delivery system components.
7.2.3.9 Tubing tensile strength
Determine the strength of the tubing used in the delivery system as appropriate to the material.
7.2.4 Biocompatibility
Biocompatibility should be tested in accordance with ISO 10993-1 and appropriate other parts of the
ISO 10993 series.
7.2.5 Haemostasis
7.2.5.1 General
The ability of the system to minimize blood loss shall be evaluated.
Hazards to be evaluated include, but are not limited to, the following:
a) size mismatch;
b) seal incompetence;
c) other leakage.
These hazards can result in the following reportable clinical events, including but not limited to the following:
 procedural bleeding;
 haematoma.
Testing shall include the following items listed in 7.2.5.2 and 7.2.5.3, as appropriate to the design of the
endovascular system.
7.2.5.2 Dimensional verification
Determine the appropriate dimensions for conformance with design specifications.
7.2.5.3 Assessment of haemostasis
Evaluate the ability of any seal or valve in the delivery system to maintain an adequate haemostatic seal.
10 © ISO 2003 — All rights reserved

ISO 25539-1:2003(E)
7.3 Implant
7.3.1 Ability to accurately deploy
7.3.1.1 General
The ability of the system to permit safe, consistent and accurate deployment of the implant at the intended
lesion location shall be evaluated.
Hazards to be evaluated include, but are not limited to, the following:
a) inaccurate positioning or orientation;
b) improper deployment configuration;
c) incomplete deployment;
d) inadequate visualization.
These hazards can result in the following reportable clinical events, including but not limited to the following:
 branch vessel occlusion;
 delivery system failure;
 attachment site leak;
 prosthesis migration;
 lumen obstruction;
 ischaemia;
 aneurysm enlargement;
 aneurysm rupture;
 vascular trauma.
Testing shall include the following items listed in 7.3.1.2 through 7.3.1.4, as appropriate to the design of the
endovascular system.
7.3.1.2 Implant length to diameter relationship
Determine the relationship between implant length and expanded implant diameter.
7.3.1.3 Visibility
Evaluate the ability to visualize the implant during deployment and after withdrawal using fluoroscopy. The use
of other technologies shall be justified.
7.3.1.4 Simulated use
Evaluate the performance of the endovascular system using a model that simulates the intended use
conditions.
ISO 25539-1:2003(E)
7.3.2 Fixation effectiveness
7.3.2.1 General
The ability of the system to permit effective fixation of the implant within the vasculature shall be evaluated.
Hazards to be evaluated include, but are not limited to, the following:
a) incomplete apposition to vessel wall;
b) excessive or inadequate radial outward force.
These hazards can result in the following reportable clinical events, including but not limited to the following:
 attachment site leak;
 prosthesis migration;
 lumen obstruction;
 vascular trauma;
 trauma to adjacent structures;
 branch vessel occlusion;
 aneurysm enlargement;
 aneurysm rupture.
Testing shall include the following items in 7.3.2.2 through 7.3.2.8, as appropriate to the design of the
endovascular system.
7.3.2.2 Conformability to vessel wall
Evaluate the ability of the implant to maintain adequate contact with the vessel wall.
7.3.2.3 Crush resistance
Determine the minimum force at which permanent deformation or full collapse occurs.
7.3.2.4 Local compression
Determine the elastic deformation of the implant in response to localized compressive force.
7.3.2.5 Migration resistance
Determine the ability of the implant to remain stationary under simulated use.
7.3.2.6 Radial outward force
The force exerted by a self-expanding implant shall be measured as a function of the implant diameter.
7.3.2.7 Recoil
Determine the amount of device diameter elastic recoil (percent of device diameter reduction) after the
deployment of the implant. Correlate this recoil to recommended sizing.
12 © ISO 2003 — All rights reserved

ISO 25539-1:2003(E)
7.3.2.8 Simulated use
Evaluate the performance of the endovascular system using a model that simulates the intended use
conditions.
7.3.3 Implant integrity
7.3.3.1 General
The ability of the implant to maintain integrity shall be evaluated.
Hazards to be evaluated include, but are not limited to, the following:
a) structural failure of implant;
b) loss of complete apposition to vessel wall;
c) leaking.
These hazards can result in the following reportable clinical events, including but not limited to the following:
 stent/attachment system fracture;
 graft dilatation/rupture;
 implant thrombosis;
 prosthesis migration;
 attachment site leak;
 aneurysm enlargement;
 aneurysm rupture;
 transgraft leak;
 vascular trauma;
 lumen obstruction/stenosis;
 ischaemia;
 trauma to adjacent structures.
Testing shall include the following items listed in 7.3.3.2 through 7.3.3.9, as appropriate to the design of the
endovascular system.
7.3.3.2 Burst/circumferential strength
Determine the burst strength and/or the circumferential strength of the appropriate components of the implant
and of the finished product in accordance with ISO 7198:1998, 8.3.3 or 8.3.1, respectively.
7.3.3.3 Corrosion
Evaluate the susceptibility of the material(s) to corrosion in an actual or simulated environment.
ISO 25539-1:2003(E)
7.3.3.4 Factory anastomotic strength
Determine the tensile strength of any manufactured anastomosis in accordance with ISO 7198:1998, 8.3.2.4.
7.3.3.5 Durability
7.3.3.5.1 General
The following items shall be considered in evaluating durability:
 potential failure modes, such as wear, strut fracture, weave separation, delamination, and suture breaks;
 radial and axial loads, and other in vivo loads.
These items shall be considered in the context of anatomic variability and morphologic changes.
7.3.3.5.2 Stress/strain analysis
Evaluate the stress/strain characteristics of the implant when subjected to a worst-case physiological load
using appropriate tools, such as Finite Element Analysis (FEA).
7.3.3.5.3 Fatigue
Evaluate the long-term dimensional and structural integrity of the implant. This includes the integrity of all
parts of the implant and their connections and contact areas among each other.
Fatigue testing of the implant shall include in vitro testing until 10 years equivalent cycles (at least 380 million)
have been applied to each device under test. If the intended implant life is less than 10 ye
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