EN 14299:2004

SLOVENSKI STANDARD
01-november-2004
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Non active surgical implants - Particular requirements for cardiac and vascular implants -
Specific requirements for arterial stents
Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und
Gefäßimplantate - Spezielle Anforderungen an Arterienstents
Implants chirurgicaux non actifs - Exigences particulieres s'appliquant aux implants
cardiaques et vasculaires - Exigences spécifiques relatives aux endoprotheses
artérielles
Ta slovenski standard je istoveten z: EN 14299:2004
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 14299
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2004
ICS 11.040.40
English version
Non active surgical implants - Particular requirements for cardiac
and vascular implants - Specific requirements for arterial stents
Implants chirurgicaux non actifs - Exigences particulières Nichtaktive chirurgische Implantate - Besondere
s'appliquant aux implants cardiaques et vasculaires - Anforderungen an Herz- und Gefäßimplantate - Spezielle
Exigences spécifiques relatives aux endoprothèses Anforderungen an Arterienstents
artérielles
This European Standard was approved by CEN on 2 February 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 14299:2004: E
worldwide for CEN national Members.

Contents
page
Foreword.3
Introduction.5
1 Scope .6
2 Normative references .6
3 Terms and definitions .7
4 Intended performance .9
5 Design attributes .9
6 Materials .9
7 Design evaluation .10
8 Manufacturing .26
9 Sterilization.26
10 Packaging.27
11 Information supplied by the manufacturer .27
Annex A (informative)  Cross reference of specific aims .29
Annex B (informative)  Definitions of reportable clinical events.33
Annex ZA (informative)  Clauses of this European Standard addressing essential
requirements or other provisions of EU Directives .37
Bibliography.38
Foreword
This document (EN 14299:2004) has been prepared by the Technical Committee CEN/TC 285
“Non-active surgical implants”, the secretariat of which is held by NEN.
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 2004, and conflicting national
standards shall be withdrawn at the latest by November 2004.
This document has been prepared under a mandate given to CEN by the Commission of the
European Community and the European Free Trade Association, and supports Essential
Requirements of EC Directive(s).
For relationship with the EC Council Directive 93/42/EEC of June 14, 1993. see informative
Annex ZA, which is an integral part of this document.
There are three levels of European Standards dealing with non-active surgical implants. These
are as follows, with level 1 being highest:
Level 1: General requirements for non-active surgical implants;
Level 2: Particular requirements for families of non-active surgical implants;
Level 3: Specific requirements for types of non-active surgical implants.
This standard is a level 3 standard and contains requirements that apply to specific types of
implants within a family.
The level 1 standard, EN ISO 14630, contains requirements that apply to all non-active surgical
implants. It also indicates that there are additional requirements in the level 2 and level 3
standards.
The level 2 standards apply to a more restricted set or family of implants such as those designed
for use in osteosynthesis, cardiovascular surgery, or joint replacement.
NOTE For cardiac and vascular implants three level 2 standards have been published:
EN 12006-1, Non-active surgical implants - Particular requirements for cardiac and vascular implants -
Part 1: Heart valve substitutes.
EN 12006-2, Non-active surgical implants - Particular requirements for cardiac and vascular implants -
Part 2: Vascular prostheses including cardiac valve conduits.
EN 12006-3, Non-active surgical implants - Particular requirements for cardiac and vascular implants -
Part 3: Endovascular devices.
To address all requirements, it is necessary to start with a standard of the lowest available level.
References to other European or International Standards can also be found in the Bibliography.
Annexes A and B are informative.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Introduction
In addition to EN ISO 14630 and EN 12006-3 this European Standard provides minimum
requirements for sterile arterial stents and endovascular prostheses and the methods of test for
their evaluation.
1 Scope
This European Standard specifies specific requirements for arterial stents and endovascular
prostheses and their deployment intended to correct or compensate for a defect of an artery.
With regard to safety, this standard gives in addition to EN ISO 14630 and
EN 12006-3 specific requirements for intended performance, design attributes, materials, design
evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
This European Standard applies to arterial stents and endovascular prostheses used in the aorta,
cervical segments of cerebral arteries, coronary arteries, intra-cerebral arteries, peripheral
arteries, pulmonary arteries, supra-aortic arteries and visceral arteries. It also includes
endovascular prostheses used to treat aneurysms, arterial stenoses, or other vascular
abnormalities.
NOTE 1 Delivery systems are included in this standard if they comprise an integral component of the
deployment of the implant.
NOTE 2 Covered stents used as occluders are included in this standard.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text, and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
EN ISO 10555-1:1996, Sterile, single-use intravascular catheters – Part 1: General requirements
(ISO 10555-1:1996).
EN ISO 10555-4:1997, Sterile, single-use intravascular catheters – Part 4: Balloon dilatation
catheters (ISO 10555-4:1996).
EN ISO 11070, Sterile single-use intravascular catheter introducers (ISO 11070:1998).
EN 12006-2:1998, Non-active surgical implants – Particular requirements for cardiac and
vascular implants – Part 2: Vascular prostheses including cardiac valve conduits.
EN 12006-3:1998, Non-active surgical implants – Particular requirements for cardiac and
vascular implants – Part 3: Endovascular devices.
EN ISO 14155-1, Clinical investigation of medical devices for human subjects – Part 1: General
requirements (ISO 14155-1:2003).
EN ISO 14155-2, Clinical investigation of medical devices for human subjects – Part 2: Clinical
investigation plans (ISO 14155-2:2003).
EN ISO 14630:1997, Non-active surgical implants – General requirements (ISO 14630:1997).
3 Terms and definitions
For the purposes of this European Standard, the terms and definitions given in EN 12006-3:1998
and the following apply.
3.1
arterial stent
implantable tubular structure which supports an arterial conduit. This includes endovascular
prostheses
3.2
bare stent
stent that is not covered or coated
3.3
cervical segments of cerebral arteries
extracranial segments of the internal carotid and vertebral arteries
3.4
crush resistance
ability of an implant to withstand load until permanent (or plastic) deformation or full collapse
occurs
3.5
delivery system
system or mechanism used to deliver the implant to the targeted position which is then removed
3.6
direct stenting
placement of the implant without prior balloon dilatation
3.7
dogboning
dumbbell-shaped deformity observed during direct stenting if the proximal and distal ends of the
balloon expand beyond the dilated implant diameter
3.8
endoleak
persistence of blood flow outside the lumen of an implant but within an aneurysm sac or adjacent
vascular segment being treated by the graft. Endoleaks are categorized as follows:
type I endoleak is periprosthetic and occurs at the proximal or the distal attachment zones;
type II endoleak is caused by retrograde flow from collateral arterial branches;
type III endoleak arises from a defect in the graft fabric, or inadequate seal or disconnection
of modular graft components;
type IV endoleak is due to graft permeability, often resulting in a generalized mild blush of
contrast medium within the aneurysm sac
3.9
endovascular prosthesis
transluminally placed vascular prosthesis, e.g. a stent graft, residing partially or completely within
a vascular conduit to form an internal bypass or shunt between sections of the vascular system
3.10
implant
arterial stent or endovascular prosthesis
3.11
implant free surface area
percentage of the surface area of the cylinder formed by the implant frame, which is not covered
by implant material
3.12
implant recoil
amount by which the diameter of an implant changes from its initial diameter when still on its fully
inflated delivery system to its relaxed final diameter after deflating the system, expressed as a
percentage of the diameter measured when still on the fully inflated delivery system
3.13
MRI compatibility
the implant is MRI compatible if, when used in a specified MRI environment:
it has been demonstrated not to significantly affect the quality of the diagnostic information;
and
the implant function is not affected by the MRI environment
3.14
nominal condition
diameter and length of the implant as stated by the manufacturer for the relaxed implant after
expansion
3.15
outer package
container for the unit package(s), designed to protect from damage due to storage and/or
transportation
3.16
patency
ability of an implant to maintain an open lumen following implantation
3.17
radial outward force (for self-expanding implants)
force exerted by a self-expanding implant as a function of the implant diameter
3.18
reference device
implant or delivery system chosen to compare methods and/or results for testing
3.19
self-expanding implant
implant where the diameter is increased from its pre-deployed size to its post-deployed size
without requiring plastic deformation
3.20
supra-aortic arteries
supra-aortic arteries begin at the aortic arch and extend up to the bifurcation of
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