SIST EN ISO 25539-1:2009
(Main)Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)
ISO 25539-1:2003 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.
ISO 25539-1:2003 is applicable to endovascular prostheses used to treat arterial aneurysms, arterial stenoses, or other appropriate vascular abnormalities.
ISO 25539-1:2003 is applicable to delivery systems if they comprise an integral component of the deployment of the endovascular prostheses.
ISO 25539-1:2003 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.
ISO 25539-1:2003 is not applicable to procedures and devices used prior to the introduction of the endovascular system, such as balloon angioplasty devices.
Kardiovaskuläre Implantate - Endovaskuläre Implantate - Teil 1: Endovaskuläre Prothesen (ISO 25539-1:2003, einschließlich Amd 1:2005)
1.1 Dieser Teil der ISO 25539 legt auf der Grundlage des derzeitigen medizinischen Wissenstandes Anforderungen
an endovaskuläre Prothesen fest. Im Hinblick auf die Sicherheit enthält er Anforderungen an die
beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe/Materialien, die Bewertung der Konstruktion, die
Herstellung, die sterile Verpackung sowie die Bereitstellung von Informationen durch den Hersteller. Er sollte
als Ergänzung zur ISO 14630 angesehen werden, die allgemeine Anforderungen an die Funktion nichtaktiver
chirurgischer Implantate festlegt.
1.2 Dieser Teil der ISO 25539 gilt für endovaskuläre Prothesen zur Behandlung arterieller Aneurysmen,
arterieller Stenosen oder sonstiger entsprechender vaskulärer Anomalien.
1.3 Dieser Teil der ISO 25539 gilt für Einführsysteme, sofern diese einen integralen Bestandteil bei der
Entfaltung der endovaskulären Prothese darstellen.
1.4 Dieser Teil der ISO 25539 gilt nicht für Gefäß-Okkluder, mit Ausnahme von kontralateralen iliakalen
Okkludern, sofern diese als integraler Bestandteil eines aorto-uni-iliakalen Implantats verwendet werden.
Siehe ISO 14630 zu den ausgenommenen Produkten.
1.5 Dieser Teil der ISO 25539 gilt nicht für Verfahren und Implantate, die vor der Einführung des endovaskulären
Systems (definiert unter 3.6) verwendet wurden, wie z. B. durch Ballonangioplastie eingebrachte
Implantate.
Implants cardiovasculaires - Dispositifs endovasculaires - Partie 1: Prothèses endovasculaires (ISO 25539-1:2003, Amd 1:2005 inclus)
L'ISO 25539-1 spécifie les exigences relatives aux prothèses endovasculaires, définies sur la base des connaissances médicales actuelles. En matière de sécurité, elle définit des exigences relatives aux performances prévues, aux caractéristiques de conception, aux matériaux, à l'évaluation de la conception, à la fabrication, la stérilisation, l'emballage et les informations fournies par le fabricant. Il convient de considérer cette norme comme un complément à l'ISO 14630, qui spécifie les exigences générales relatives aux performances des implants chirurgicaux non actifs.
Le domaine d'application de l'ISO 25539-1 inclut les prothèses endovasculaires utilisées dans le traitement des anévrysmes artériels, des sténoses artérielles ou d'autres anomalies vasculaires.
Les systèmes de largage sont inclus dans l'ISO 25539-1 s'ils font partie intégrante du système de mise en place des prothèses endovasculaires.
Les dispositifs d'occlusion vasculaire ne sont pas abordés dans l'ISO 25539-1, sauf lorsqu'il s'agit de dispositifs d'occlusion iliaque contralatérale utilisés comme partie intégrante d'un dispositif aorto-uni-iliaque. Voir l'ISO 14630 pour les produits exclus.
Les techniques et les dispositifs utilisés avant l'introduction du système endovasculaire, tels que les dispositifs d'angioplastie transluminale percutanée, sont exclus du domaine d'application de l'ISO 25539-1.
Vsadki (implantati) za srce in ožilje - Znotrajžilni pripomočki - 1. del: Znotrajžilne proteze (ISO 25539-1:2003, vključno z Amd 1:2005)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 25539-1:2009
01-julij-2009
1DGRPHãþD
SIST EN 12006-3:2000+A1:2009
SIST EN ISO 25539-1:2009
9VDGNL LPSODQWDWL ]DVUFHLQRåLOMH=QRWUDMåLOQLSULSRPRþNLGHO =QRWUDMåLOQH
SURWH]H ,62 YNOMXþQR]$PG
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
SIST EN ISO 25539-1:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 25539-1:2009
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SIST EN ISO 25539-1:2009
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.
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SIST EN ISO 25539-1:2009
EN ISO 25539-1:2009 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 25539-1:2009
EN ISO 25539-1:2009 (E)
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
EN ISO 25539-1:2009 by Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of
which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical
text or by endorsement, at the latest by 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.
3
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SIST EN ISO 25539-1:2009
EN ISO 25539-1:2009 (E)
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.
4
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SIST EN ISO 25539-1:2009
EN ISO 25539-1:2009 (E)
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.
5
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SIST EN ISO 25539-1:2009
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SIST EN ISO 25539-1:2009
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
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SIST EN ISO 25539-1:2009
ISO 25539-1:2003(E)
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Published in Switzerland
ii © ISO 2003 — All rights reserved
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SIST EN ISO 25539-1:2009
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 2003 — All rights reserved iii
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SIST EN ISO 25539-1:2009
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
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SIST EN ISO 25539-1:2009
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.
© ISO 2003 — All rights reserved v
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SIST EN ISO 25539-1:2009
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SIST EN ISO 25539-1:2009
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 2003 — All rights reserved 1
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SIST EN ISO 25539-1:2009
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
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SIST EN ISO 25539-1:2009
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 2003 — All rights reserved 3
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SIST EN ISO 25539-1:2009
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
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SIST EN ISO 25539-1:2009
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 2003 — All rights reserved 5
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SIST EN ISO 25539-1:2009
ISO 25539-1:2003(E)
These hazards can result in the following reportable
...
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.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)Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2003 including Amd 1:2005)11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:prEN ISO 25539-1kSIST prEN ISO 25539-1:2009en01-marec-2009kSIST prEN ISO 25539-1:2009SLOVENSKI
STANDARD
kSIST prEN ISO 25539-1:2009
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMFINAL DRAFTprEN ISO 25539-1December 2008ICS 11.040.40Will supersede EN ISO 25539-1:2008
English VersionCardiovascular implants - Endovascular devices - Part 1:Endovascular prostheses (ISO 25539-1:2003 including Amd1:2005)Implants cardiovasculaires - Dispositifs endovasculaires -Partie 1: Prothèses endovasculaires (ISO 25539-1:2003,Amd 1:2005 inclus)Kardiovaskuläre Implantate - Endovaskuläre Implantate -Teil 1: Endovaskuläre Prothesen (ISO 25539-1:2003,einschließlich Amd 1:2005)This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the TechnicalCommittee CEN/TC 285.If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations whichstipulate the conditions for giving this European Standard the status of a national standard without any alteration.This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other languagemade by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has thesame 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.Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice andshall not be referred to as a European Standard.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre:
Avenue Marnix 17,
B-1000 Brussels© 2008 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. prEN ISO 25539-1:2008: EkSIST prEN ISO 25539-1:2009
prEN ISO 25539-1:2008 (E) 2 Contents Page Foreword .3Annex ZA (informative)
Relationship between this
European
Standard and the Essential Requirements
of EU Directive 93/42/EEC .4 kSIST prEN ISO 25539-1:2009
prEN ISO 25539-1:2008 (E) 3 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 prEN ISO 25539-1:2008 by Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. This document is currently submitted to the Unique Acceptance Procedure. This document will supersede 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 EC Directive. For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document. Endorsement notice The text of ISO 25539-1:2003 including Amd 1:2005 has been approved by CEN as a prEN ISO 25539-1:2008 without any modification. kSIST prEN ISO 25539-1:2009
prEN ISO 25539-1:2008 (E) 4 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 EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 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 - 7.6 - 8.2 - 9.2
ER 7.4 includes a mandatory 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 - 8.3 - 8.4 ER 7.4 includes a mandatory consultation of regulatory authorities in relation to medicinal substances that is not addressed in this European Standard.
kSIST prEN ISO 25539-1:2009
prEN ISO 25539-1:2008 (E) 5
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.
kSIST prEN ISO 25539-1:2009
kSIST prEN ISO 25539-1:2009
Reference numberISO 25539-1:2003(E)© ISO 2003
INTERNATIONAL STANDARD ISO25539-1First edition2003-03-01Cardiovascular implants — Endovascular devices —
Part 1: Endovascular prostheses Implants cardiovasculaires — Dispositifs endovasculaires — Partie 1: Prothèses endovasculaires
kSIST prEN ISO 25539-1:2009
ISO 25539-1:2003(E) PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
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ii © ISO 2003 — All rights reserved
kSIST prEN ISO 25539-1:2009
ISO 25539-1:2003(E) © ISO 2003 — All rights reserved iii 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
kSIST prEN ISO 25539-1:2009
ISO 25539-1:2003(E) iv © ISO 2003 — All rights reserved 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
kSIST prEN ISO 25539-1:2009
ISO 25539-1:2003(E) © ISO 2003 — All rights reserved v 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.
kSIST prEN ISO 25539-1:2009
kSIST prEN ISO 25539-1:2009
INTERNATIONAL STANDARD ISO 25539-1:2003(E) © ISO 2003 — All rights reserved 1 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 kSIST prEN ISO 25539-1:2009
ISO 25539-1:2003(E) 2 © ISO 2003 — All rights reserved 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 kSIST prEN ISO 25539-1:2009
ISO 25539-1:2003(E) © ISO 2003 — All rights reserved 3 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. kSIST prEN ISO 25539-1:2009
ISO 25539-1:2003(E) 4 © ISO 2003 — All rights reserved 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. kSIST prEN ISO 25539-1:2009
ISO 25539-1:2003(E) © ISO 2003 — All rights reserved 5 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. kSIST prEN ISO 25539-1:2009
ISO 25539-1:2003(E) 6 © ISO 2003 — All rights reserved 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. kSIST prEN ISO 25539-1:2009
ISO 25539-1:2003(E) © ISO 2003 — All rights reserved 7 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 deplo
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