EN ISO 14607:2009

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

ISO 14607:2007 specifies particular requirements for mammary implants for clinical practice.
With regard to safety, ISO 14607:2007 specifies requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer.

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

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

L'ISO 14607:2007 spécifie les exigences particulières relatives aux implants mammaires destinés à des fins cliniques.
En matière de sécurité, l'ISO 14607:2007 spécifie des exigences relatives aux performances prévues, aux caractéristiques de conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à la stérilisation, à l'emballage et aux informations fournies par le fabricant.

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

General Information

• Status: Withdrawn
• Publication Date: 12-May-2009
• Withdrawal Date: 15-May-2018
• 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
• Completion Date: 16-May-2018
• 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
• Mandate: M/320 - Standardization mandate to CEN concerning the development of European standards relating to medical devices (subject: breast implants)
• Ref Project: SIST EN ISO 14607:2009 - Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)

Relations

• Replaces: EN ISO 14607:2007 - Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2007)
• Effective Date: 20-May-2009
• Replaced By: EN ISO 14607:2018 - Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018, Corrected version 2018-08)
• Effective Date: 30-Oct-2013

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2009
1DGRPHãþD
SIST EN ISO 14607:2007
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 particulières (ISO
14607:2007)
Ta slovenski standard je istoveten z: EN ISO 14607:2009
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
May 2009
ICS 11.040.40 Supersedes EN ISO 14607:2007
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 19 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 Ref. No. EN ISO 14607:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

Foreword
The text of ISO 14607:2007 has been prepared by Technical Committee ISO/TC 150 “Implants for surgery” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 14607:2009 by
Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN.
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 November 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14607:2007.
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 EC Directive.
For relationship with EC Directive, 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 the United Kingdom.
Endorsement notice
The text of ISO 14607:2007 has been approved by CEN as a EN ISO 14607:2009 without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on 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 clauses of this
standard given in table ZA 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 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying remarks/Notes
EN 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 - 6.a - 7.1 - 7.2
- 7.3 - 7.5 - 7.6 - 8 - 9.1 - 9.2
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 Subclause 11.7 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).
The part of ER 13.3.a
concerning the information on
the authorized representative is
not addressed in this European
Standard
ER 13.6.q) This relevant
Essential Requirement is not
addressed in this European
Standard.
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
...