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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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.
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 International Standard and Directive 93/42/EEC
Medical Devices
Clause(s)/sub-clause(s) of
Essential requirements (ERs) Qualifying remarks/Notes
this International Standard
of EU Directive 93/42/EEC
4 1 - 2 - 3 - 4 - 7.1
5 1 - 2 - 3 - 4 - 5 - 7.1 - 7.2 - 7.3 -
7.5 - 7.6 - 8 - 9.1 - 9.2
6 1 - 2 - 7.1 - 7.2 - 7.3 - 7.4 - 7.5 -
8.2 - 9.2
7 1 - 2 - 3 - 4 - 5 - 6 - 7.1 - 7.2 -
7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2 - 14
8 1 - 2 - 3 - 5 - 7.1 - 7.2
9 1 - 2 - 7.2 - 8.1 - 8.3 - 8.4
10 1 - 2 - 3 - 5 - 7.2 - 8.3 - 8.6
11 1 - 2 - 13 11.6 requires that the information
detailed in Annex F be given to the
patient by the medical staff, in
accordance with the Essential
Requirements 13.6 k) and l).
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
INTERNATIONAL ISO
STANDARD 14607
Second edition
2007-02-15
Non-active surgical implants — Mammary
implants — Particular requirements
Implants chirurgicaux non actifs — Implants mammaires — Exigences
particulières
Reference number
ISO 14607:2007(E)
©
ISO 2007
ISO 14607:2007(E)
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ISO 14607:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Intended performance . 2
5 Design attributes. 2
6 Materials . 3
7 Design evaluation . 3
7.1 General. 3
7.2 Pre-clinical evaluation. 3
7.3 Clinical evaluation . 6
7.4 Post-market surveillance . 7
8 Manufacturing . 7
9 Sterilization. 7
10 Packaging . 7
11 Information supplied by the manufacturer .7
11.1 General. 7
11.2 Resterilization . 8
11.3 Base dimensions . 8
11.4 Effects on diagnostic techniques . 8
11.5 Filling materials. 8
11.6 Information on expected lifetime . 8
11.7 Information for the patient . 8
11.8 Labels. 9
11.9 Information for the user . 9
11.10 Marking on implants. 9
11.11 Manufacturer’s device card . 9
Annex A (normative) Test for surface characteristics . 10
Annex B (normative) Tests for shell integrity . 11
Annex C (normative) Test method for valve competence and injection site competence. 13
Annex D (normative) Test for silicone gel cohesion (silicone filling materials only) . 15
Annex E (normative) Mechanical tests on a mammary implant in its implantable state. 17
Annex F (normative) Information for the patient . 22
Annex G (normative) Information for the user . 24
Annex H (informative) Silicone release assessment from mammary implants by an in vitro
method . 25
Bibliography . 28
ISO 14607:2007(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
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International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 14607 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 285, Non-active surgic
...
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