EN 12006-2:1998/prA1

Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

Nichtaktive chirurgische Implantate - Besondere Anforderungen für Herz- und Gefäßimplantate - Teil 2: Gefäßprothesen, einschließlich Herzklappen-Gefäßstutzen

Implants chirurgicaux non actifs - Exigences particulières pour les implants cardio-vasculaires - Partie 2 : Prothèses vasculaires y compris les conduits valvulés

Neaktivni kirurški vsadki (implantati) - Posebne zahteve za srčnožilne vsadke (kardiovaskularne implantate) - 2. del: Žilne proteze, vključno s cevastimi vsadki s srčnimi zaklopkami (tubularnimi grafti)

General Information

• Status: Not Published
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: CEN/TC 285 - Non-active surgical implants
• Drafting Committee: CEN/TC 285/WG 3 - Cardiac and vascular implants
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 04-Mar-2009
• Completion Date: 04-Mar-2009
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 12006-2:2000/kprA1:2009 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits

Relations

• Merged Into: EN 12006-2:1998+A1:2009 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
• Effective Date: 18-Jan-2023
• Amends: EN 12006-2:1998 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 2: Vascular prostheses including cardiac valve conduits
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2009
1HDNWLYQLNLUXUãNLYVDGNLLPSODQWDWL3RVHEQH]DKWHYH]DVUþQRåLOQHYVDGNH
NDUGLRYDVNXODUQHLPSODQWDWHGHOäLOQHSURWH]HYNOMXþQRVFHYDVWLPLYVDGNLV
VUþQLPL]DNORSNDPLWXEXODUQLPLJUDIWL
Non active surgical implants - Particular requirements for cardiac and vascular implants -
Part 2: Vascular prostheses including cardiac valve conduits
Nichtaktive chirurgische Implantate - Besondere Anforderungen für Herz- und
Gefäßimplantate - Teil 2: Gefäßprothesen, einschließlich Herzklappen-Gefäßstutzen
Implants chirurgicaux non-actifs - Exigences particulières relatives aux implants
cardiaques et vasculaires - Partie 3: Dispositifs endovasculaires
Ta slovenski standard je istoveten z: EN 12006-2:1998/prA1
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
FINAL DRAFT
EN 12006-2:1998
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
December 2008
ICS 11.040.40
English Version
Non active surgical implants - Particular requirements for cardiac
and vascular implants - Part 2: Vascular prostheses including
cardiac valve conduits
Implants chirurgicaux non actifs - Exigences particulières Nichtaktive chirurgische Implantate - Besondere
pour les implants cardio-vasculaires - Partie 2: Prothèses Anforderungen für Herz- und Gefäßimplantate - Teil 2:
vasculaires y compris les conduits valvulés Gefäßprothesen, einschließlich Herzklappen-Gefäßstutzen
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 285.
This draft amendment A1, if approved, will modify the European Standard EN 12006-2:1998. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN 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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 12006-2:199
...