SIST EN 12006-3:2000+A1:2009
(Main)Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
This European Standard specifies particular requirements for endovascular devices.
With regard to safety, this standard gives in addition to EN ISO 14630, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.
NOTE 1 Vascular occluders are not addressed in this standard. For the time being the requirements as stated in EN ISO 14630:1997 apply for these products.
NOTE 2 Due to the variations in the design of the implants covered by this standard and in some cases due to the relatively recent development of some of these implants, acceptable standardized in vitro tests and long term results of clinical trials are not always available.
Where no test method is described in this standard a complete description of the validated test method and sample preparation procedure used should be documented by the manufacturer. With regard to design evaluation, where a specific standardized test is not described, guidance is given by referring to current scientific literature (see Annex A). This standard aims to ensure that manufacturers will address all aspects of design evaluation that relate to the safety of the product. As further scientific and clinical data become available, appropriate revision of the standard will be necessary.
Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und Gefäßimplantate - Teil 3: Endovaskuläre Implantate
Diese Europäische Norm legt Anforderungen an endovaskuläre Implantate fest.
In bezug auf die Sicherheit legt diese Norm in Ergänzung zu EN ISO 14630:1997 Anforderungen für die
beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Bewertung der Konstruktion, Fertigung,
Sterilisation, Verpackung und die Bereitstellung von Informationen durch den Hersteller, fest.
ANMERKUNG 1 Blutgefäßklemmen werden durch diese Norm nicht abgedeckt. Zur Zeit gelten für diese Produkte die in
EN ISO 14630:1997 festgelegten Anforderungen.
ANMERKUNG 2 Aufgrund der Vielfalt der Ausführung der durch diese Norm abgedeckten Implantate und in einigen
Fällen durch die relativ schnelle Weiterentwicklung einiger dieser Implantate sind geeignete genormte in-vitro
Prüfverfahren und Ergebnisse von klinischen Langzeiterprobungen nicht immer verfügbar.
Sofern in dieser Norm keine Prüfverfahren beschrieben sind, sollte der Hersteller eine vollständige Beschreibung des
verwendeten validierten Prüfverfahrens und der Vorbereitung der Prüflinge erstellen. Sofern bezüglich der Bewertung der
Konstruktion keine genormten Verfahren festgelegt sind, wird empfohlen auf aktuelle wissenschaftliche Literatur zu
verweisen (siehe Anhang A). Das Ziel dieser Norm ist, sicherzustellen, dass der Hersteller in bezug auf die Sicherheit des
Produktes alle Aspekte der Bewertung der Konstruktion berücksichtigt. Sobald weitere wissenschaftliche und klinische
Daten verfügbar sind, wird es notwendig sein, diese Norm entsprechend zu überarbeiten.
Implants chirurgicaux non-actifs - Exigences particulières pour les implants cardio-vasculaires - Partie 3: Dispositifs endovasculaires
La présente norme européenne spécifie des exigences particulières relatives aux dispositifs endovasculaires.
En ce qui concerne la sécurité, la présente norme indique en complément à l'EN ISO 14630:1997, des exigences
relatives aux performances prévues, aux attributs de conception, aux matériaux, à l'évaluation de la conception,
à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant.
NOTE 1 Les systèmes d'occlusion vasculaires ne sont pas abordés dans la présente norme. Pour l'instant, ces produits sont
soumis aux exigences données dans l'EN ISO 14630:1997.
NOTE 2 Étant donné que la conception des implants couverts par la présente norme est variable et que, dans certains cas,
ces implants sont très récents, des essais in vitro normalisés acceptables ou des résultats d'essais cliniques sur une longue
durée ne sont pas toujours disponibles.
Lorsque aucune méthode d'essai n'est décrite dans le présente norme, il convient que le fabricant en donne par écrit une
description complète après validation et qu'il décrive également la méthode d'échantillonnage qu'il a utilisée. En ce qui
concerne l'évaluation de la conception, lorsqu'un essai normalisé particulier n'est pas décrit, des recommandations sont
données par référence à la littérature scientifique actuelle (voir l'Annexe A). La présente norme permettra aux fabricants de
tenir compte de tous les aspects relatifs à l'évaluation de la conception, liés à la sécurité du produit. Une révision appropriée
de la présente norme sera entreprise une fois que d'autres résultats scientifiques et cliniques seront disponibles.
Neaktivni kirurški vsadki (implantati) - Posebne zahteve za srčnožilne vsadke (kardiovaskularni implantati) - 3. del: Znotrajžilni pripomočki
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und Gefäßimplantate - Teil 3: Endovaskuläre ImplantateImplants chirurgicaux non-actifs - Exigences particulières pour les implants cardio-vasculaires - Partie 3: Dispositifs endovasculairesNon active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices11.040.40Implantanti za kirurgijo, protetiko in ortetikoImplants for surgery, prosthetics and orthoticsICS:Ta slovenski standard je istoveten z:EN 12006-3:1998+A1:2009SIST EN 12006-3:2000+A1:2009en,fr,de01-julij-2009SIST EN 12006-3:2000+A1:2009SLOVENSKI
STANDARD
SIST EN 12006-3:2000+A1:2009
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 12006-3:1998+A1
May 2009 ICS 11.040.40 Supersedes EN 12006-3:1998English Version
Non active surgical implants - Particular requirements for cardiacand vascular implants - Part 3: Endovascular devices
Implants chirurgicaux non-actifs - Exigences particulières pour les implants cardio- vasculaires - Partie 3: Dispositifs endovasculaires
Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und Gefäßimplantate - Teil 3: Endovaskuläre Implantate This European Standard was approved by CEN on 8 November 1998 and includes Amendment 1 approved by CEN on 5 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 worldwide for CEN national Members. Ref. No. EN 12006-3:1998+A1:2009: ESIST EN 12006-3:2000+A1:2009
EN 12006-3:1998+A1:2009 (E) 2 Contents Page Foreword .3Introduction .41Scope .52Normative references .53Definitions .54Intended performance .55Design attributes.66Materials .67Design evaluation .68Manufacturing .99Sterilization .910Packaging .911Information supplied by the manufacturer .9Annex A (informative)
Bibliography . 10Annex B (informative)
Animal studies with stents . 12Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC"""" . 14 SIST EN 12006-3:2000+A1:2009
EN 12006-3:1998+A1:2009 (E) 3 Foreword This document (EN 12006-3:1998+A1:2009) has been prepared 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. This document includes Amendment 1, approved by CEN on 2009-04-05. This document supersedes EN 12006-3:1998. The start and finish of text introduced or altered by amendment is indicated in the text by tags !". This European Standard 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(s). !For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this standard." There are three levels of European Standards dealing with non-active surgical implants. These are as follows, with level 1 being the 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 2 standard and contains requirements that apply to all non-active surgical implants in the family of vena cava filters and vascular stents. The level 1 standard contains requirements that apply to all non-active surgical implants. Level 3 standards contain requirements that apply to specific types of implants within a family. To address all requirements, it is necessary to start with a standard of the lowest available level. References can also be found in Annex A of this standard. 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 United Kingdom.
SIST EN 12006-3:2000+A1:2009
EN 12006-3:1998+A1:2009 (E) 4 Introduction This European Standard in addition to EN ISO 14630 provides a method to demonstrate compliance with the relevant Essential Requirements as outlined in general terms in Annex 1 of the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as they apply to endovascular devices. SIST EN 12006-3:2000+A1:2009
EN 12006-3:1998+A1:2009 (E) 5 1 Scope This European Standard specifies particular requirements for endovascular devices. With regard to safety, this standard gives in addition to EN ISO 14630, requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. NOTE 1 Vascular occluders are not addressed in this standard. For the time being the requirements as stated in EN ISO 14630:1997 apply for these products. NOTE 2 Due to the variations in the design of the implants covered by this standard and in some cases due to the relatively recent development of some of these implants, acceptable standardized in vitro tests and long term results of clinical trials are not always available. Where no test method is described in this standard a complete description of the validated test method and sample preparation procedure used should be documented by the manufacturer. With regard to design evaluation, where a specific standardized test is not described, guidance is given by referring to current scientific literature (see Annex A). This standard aims to ensure that manufacturers will address all aspects of design evaluation that relate to the safety of the product. As further scientific and clinical data become available, appropriate revision of the standard will be necessary. 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. EN ISO 14630:1997, Non-active surgical implants - General requirements (ISO 14630:1997) ISO 10555-4, Sterile, single-use intravascular catheters – Part 4: Balloon dilatation catheters 3 Definitions For the purpose of this standard the definitions of EN ISO 14630 apply together with the following: 3.1 vascular stent implantable expandable tubular structure supporting a vascular conduit 3.2 vena cava filter implantable expanding filtering device to be inserted into the vena cava 3.3 stented graft a combination of one or more stents and a tubular graft 4 Intended performance The requirements of clause 4 of EN ISO 14630:1997 apply. SIST EN 12006-3:2000+A1:2009
EN 12006-3:1998+A1:2009 (E) 6 5 Design attributes The requirements of clause 5 of EN ISO 14630:1997 apply together with the following: a) oxidation-potential, the possibility of crevice corrosion, passivation level (see 7.1.3) over the relevant parts; b) with regard to wear: fretting corrosion (see 7.1.2); c) interface between implant and body (see 7): 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 device if the deformation is permanent; d) expected ingrowth, penetration, perforation, tilting and migration (see 7); e) effects by flow pattern and release of ions (see 7.1.3); f) introduction and delivery systems (see 7.1.4); g) geometry (see clause 7). 6 Materials The requirements of clause 6 of EN ISO 14630:1997 shall apply. 7 Design evaluation The requirements of clause 7 of EN ISO 14630:1997 shall apply together with the following: NOTE The effects of MRI on the implant should be evaluated during the risk analysis. 7.1 General Where no test method is described in this standard, description of the validated test method and sample preparation used in the study shall be documented by the manufacturer. The need for a reference device shall be considered. The method chosen including the choice of the reference device shall be justified. Data are required for a finite element or other stress analysis that identifies the peak stresses in the device when subjected to a worst-case physiological load. The amounts of residual stress shall be determined and accounted for when calculating safety factors. 7.1.1 Structural integrity testing The anticipated deformation profile shall be determined. For self expanding stents the forces exerted by the device on the arterial wall shall be determined. SIST EN 12006-3:2000+A1:2009
EN 12006-3:1998+A1:2009 (E) 7 7.1.2 Fatigue analysis An in-depth analysis of the implant's fatigue resistance shall be performed to assure that the arterial/venous implant conditions to which the device will be subjected will not result in device failure. When in vitro-testing is used as the primary method to evaluate fatigue, analysis to determine the device fatigue at 10 years equivalent real time should be conducted on a statistically significant sample of devices and dynamically cycled over simulated vessel conditions. NOTE Guidance can be found in Annex A1. 7.1.3 Oxidation potentials The implant shall undergo potential measurement. NOTE 1 Guidance can be found in Annex A2. NOTE 2 Where several materials are used the manufacturer should provide proof of their compatibility in terms of oxidation potential. 7.1.4 Device/catheter system The device/catheter system shall be tested to demonstrate that it can deliver the device to the intended location and that the device is not adversely affected by the catheter. Where a balloon catheter is used it shall comply with ISO 10555-4. 7.1.5 Surface The implant shall be free from defects when examined as follows: a) examine the implant visually with normal sight for process or surface defects; b) examine the surface, hooks and other appropriate aspects of the stent in a magnifier for process or surface defect; NOTE 1 Magnification of x 2.5 - 5 is recommended. c) examine particularly exposed areas
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