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CEN

EN ISO 14607:2007

(Main)

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)

Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)

BT noted  that this work in TC285 level depends on new funding by the European Commission. See document BT C 95/2002 (BT N6734) ++ Registered under VA/CEN lead further to info from ISO/CS (NT/030520).

Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO 14607:2007)

Diese Internationale Norm legt besondere Anforderungen an Mammaimplantate zur klinischen Anwendung fest.
Im Hinblick auf die Sicherheit legt diese Internationale Norm Anforderungen an die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designbewertung, Herstellung, Sterilisation, Verpackung und vom Hersteller zu liefernde Informationen fest.

Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières (ISO 14607:2007)

Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO 14607:2007)

General Information

Status
Withdrawn
Publication Date
14-Feb-2007
Withdrawal Date
12-May-2009
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 6 - Reconstructive implants
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
13-May-2009
Completion Date
13-May-2009
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
M/320 - Standardization mandate to CEN concerning the development of European standards relating to medical devices (subject: breast implants)
Ref Project
SIST EN ISO 14607:2007 - Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)

Relations

Replaces
EN 12180:2000 - Non-active surgical implants - Body contouring implants - Specific requirements for mammary implants
Effective Date
22-Dec-2008
Replaced By
EN ISO 14607:2009 - Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
Effective Date
20-May-2009

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 14607:2007
01-julij-2007
1DGRPHãþD
SIST EN 12180:2000
Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO
14607:2007)
Non-active surgical implants - Mammary implants - Particular requirements (ISO
14607:2007)
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen
(ISO 14607:2007)
Implants chirurgicaux non actifs - Implants mammaires - Exigences particulieres (ISO
14607:2007)
Ta slovenski standard je istoveten z: EN ISO 14607:2007
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 14607:2007 en;fr;de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

EUROPEAN STANDARD
EN ISO 14607
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2007
ICS 11.040.40 Supersedes EN 12180:2000
English Version
Non-active surgical implants - Mammary implants - Particular
requirements (ISO 14607:2007)
Implants chirurgicaux non actifs - Implants mammaires - Nichtaktive chirurgische Implantate - Mammaimplantate -
Exigences particulières (ISO 14607:2007) Besondere Anforderungen (ISO 14607:2007)
This European Standard was approved by CEN on 4 February 2007.
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: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14607:2007: E
worldwide for CEN national Members.

---------------------- Page: 2 ----------------------

EN ISO 14607:2007 (E)





Foreword


This document (EN ISO 14607:2007) has been prepared by Technical Committee CEN/TC 285 "Non-
active surgical implants", the secretariat of which is held by NEN, in collaboration with Technical
Committee ISO/TC 150 "Implants for surgery".

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 August 2007, and conflicting national standards
shall be withdrawn at the latest by August 2007.

This document supersedes EN 12180:2000.

This document 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
document.

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.

2

---------------------- Page: 3 ----------------------

EN ISO 14607:2007 (E)



ANNEX ZA
(informative)

Relationship between this International Standard and the
Essential Requirements of EU Directive 93/42/EEC Medical
Devices



This International Standard has been prepared under a mandate given to CEN by the European
Commission to provide one means of conforming to the Essential Requirements of the New
Approach Directive 93/42/EEC Medical Devices.

Once this standard is cited in the Official Journal of the European Communities under that Directive
and has been implemented as a national standard in at least one Member State, compliance with
the normative clauses of this standard given in Table ZA.1 confers, within the limits of the scope of
this standard, a presumption of conformity with the corresponding Essential Requirements of that
Directive and associated EFTA regulations.


Table ZA.1 — Correspondence between this Internation
...

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