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SIST

SIST EN 12006-3:2000/kprA1:2009

(Amendment)

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

Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und Gefäßimplantate - Teil 3: Endovaskuläre Implantate

Implants chirurgicaux non-actifs - Exigences particulières relatives aux implants cardiaques et vasculaires - Partie 3: Dispositifs endovasculaires

Neaktivni kirurški vsadki (implantati) - Posebne zahteve za srčnožilne vsadke (kardiovaskularni implantati) - 3. del: Znotrajžilni pripomočki

General Information

Status
Not Published
Public Enquiry End Date
04-Mar-2009
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
VAZ - Healthcare
Current Stage
5520 - Unique Acceptance Procedure (UAP) (Adopted Project)
Start Date
14-Jan-2009
Due Date
03-Jun-2009
Completion Date
03-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
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
EN 12006-3:1998/prA1 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices

Relations

Consolidated By
SIST EN 12006-3:2000+A1:2009 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
Effective Date
19-Jan-2023
Consolidated By
SIST EN 12006-3:2000+A1:2009 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
Effective Date
18-Jan-2023
Consolidated By
SIST EN 12006-3:2000+A1:2009 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
Effective Date
01-Jul-2009
Amends
SIST EN 12006-3:2000 - Non active surgical implants - Particular requirements for cardiac and vascular implants - Part 3: Endovascular devices
Effective Date
01-Mar-2009

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EN 12006-3:2000/kprA1:2009EN 12006-3:2000/kprA1:2009
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EN 12006-3:2000/kprA1:2009
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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 12006-3:2000/kprA1:2009
01-marec-2009
1HDNWLYQLNLUXUãNLYVDGNL LPSODQWDWL 3RVHEQH]DKWHYH]DVUþQRåLOQHYVDGNH
NDUGLRYDVNXODUQLLPSODQWDWL GHO=QRWUDMåLOQLSULSRPRþNL
Non active surgical implants - Particular requirements for cardiac and vascular implants -
Part 3: Endovascular devices
Nichtaktive chirurgische Implantate - Besondere Anforderungen an Herz- und
Gefäßimplantate - Teil 3: Endovaskuläre Implantate
Implants chirurgicaux non-actifs - Exigences particulières relatives aux implants
cardiaques et vasculaires - Partie 3: Dispositifs endovasculaires
Ta slovenski standard je istoveten z: EN 12006-3:1998/prA1
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN 12006-3:2000/kprA1:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 12006-3:2000/kprA1:2009

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SIST EN 12006-3:2000/kprA1:2009
EUROPEAN STANDARD
FINAL DRAFT
EN 12006-3:1998
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 3: Endovascular devices
Implants chirurgicaux non-actifs - Exigences particulières Nichtaktive chirurgische Implantate - Besondere
relatives aux implants cardiaques et vasculaires - Partie 3: Anforderungen an Herz- und Gefäßimplantate - Teil 3:
Dispositifs endovasculaires Endovaskuläre Implantate
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 12006-3:1998. 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:
...

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