EN 12006-3:1998+A1:2009
(Main + Amendment)Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
General Information
- Abstract
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.
- Status
- Withdrawn
- Publication Date
- 05-May-2009
- Withdrawal Date
- 30-Nov-2011
- Technical Committee
- CEN/TC 285 - Non-active surgical implants
- Drafting Committee
- CEN/TC 285/WG 3 - Cardiac and vascular implants
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 01-Dec-2011
- Completion Date
- 01-Dec-2011
Not Harmonized93/42/EEC - Medical devicesOJ Ref: C, C 293 OJ Date: 02-Dec-2009
Relations
- Effective Date
- 23-Mar-2009
- Effective Date
- 08-Jun-2022
- Effective Date
- 08-Jun-2022
- Effective Date
- 14-Dec-2011
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Frequently Asked Questions
EN 12006-3:1998+A1:2009 is a standard published by the European Committee for Standardization (CEN). Its full title is "Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices". This standard covers: 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.
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.
EN 12006-3:1998+A1:2009 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 12006-3:1998+A1:2009 has the following relationships with other standards: It is inter standard links to EN 12006-3:1998, EN ISO 25539-1:2009, EN ISO 25539-2:2009, EN ISO 25539-3:2011. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 12006-3:1998+A1:2009 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
EN 12006-3:1998+A1:2009 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
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
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
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
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