EN ISO 14607:2018

SLOVENSKI STANDARD
01-julij-2018
Nadomešča:
SIST EN ISO 14607:2009
Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO
14607:2018, popravljena verzija 2018-08)
Non-active surgical implants - Mammary implants - Particular requirements (ISO
14607:2018, Corrected version 2018-08)
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen
(ISO 14607:2018, korrigierte Fassung 2018-08)
Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières (ISO
14607:2018, Version corrigée 2018-08)
Ta slovenski standard je istoveten z: EN ISO 14607:2018
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.

EN ISO 14607
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2018
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 14607:2009
English Version
Non-active surgical implants - Mammary implants -
Particular requirements (ISO 14607:2018, Corrected
version 2018-08)
Implants chirurgicaux non actifs - Implants Nichtaktive chirurgische Implantate -
mammaires - Exigences particulières (ISO Mammaimplantate - Besondere Anforderungen (ISO
14607:2018) 14607:2018)
This European Standard was approved by CEN on 26 February 2018.

This European Standard was corrected and reissued by the CEN-CENELEC Management Centre on 12 December 2018.

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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
C OMITÉ EUROPÉEN DE NORMALISATIO N

EUROPÄISCHES KOMITEE FÜR NORMUN G

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 14607:2018 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered . 5

European foreword
This document (EN ISO 14607:2018) has been prepared by Technical Committee ISO/TC 150 “Implants
for surgery” in collaboration with 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 2018, and conflicting national standards
shall be withdrawn at the latest by November 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 14607:2009.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative Equivalent dated standard
references as listed
EN ISO or IEC
in Clause 2 of the
ISO standard
ISO 34-1:2015 – ISO 34-1:2015
ISO 37:2017 – ISO 37:2017
ISO 4287 EN ISO 4287:1998, ISO 4287:1997,
EN ISO 4287:1998/AC:2008 ISO 4287:1997/Cor 1:1998/Cor 2:2005 and
and ISO 4287:1997/Amd:2009
EN ISO 4287:1998/A1:2009
Normative Equivalent dated standard
references as listed
EN ISO or IEC
in Clause 2 of the
ISO standard
ISO 7619-1 – ISO 7619-1:2010
ISO 10993-1 EN ISO 10993-1:2009 and ISO 10993-1:2009 and
EN ISO 10993-1:2009/AC:2010 ISO 10993-1:2009/Cor 1:2010
ISO 10993-5 EN ISO 10993-5:2009 ISO 10993-5:2009
ISO 10993-18 EN ISO 10993-18:2009 ISO 10993-18:2005
ISO 11607-1 EN ISO 11607-1:2017 ISO 11607-1:2006 and
ISO 11607-1:2006/Amd 1:2014
ISO 14155 EN ISO 14155:2011 and ISO 14155:2011 and
EN ISO 14155:2011/AC:2011 ISO 14155:2011/Cor. 1:2011
ISO 14630:2012 EN ISO 14630:2012 ISO 14630:2012
Endorsement notice
The text of ISO 14607:2018, Corrected version 2018-08 has been approved by CEN as EN ISO
14607:2018 without any modification.

Annex ZAAnnex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request [M/023
concerning the development of European Standards related to medical devices] to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and
Annex I of Directive 93/42/EEC [OJ L 169]
Essential Requirements Clause(s)/subclause(s) of
Remarks/Notes
of directive 93/42/EEC this EN
7.5 6.2, 6.3, 6.4, 7.2.2.1 The Essential Requirement is covered
with respect to the risk posed by
silicone gel leaking from the implant.
The standard requires several tests to
establish safe composition and
properties of silicone gel. Beyond that
the standard also requires several
tests to establish the integrity of the
implant shell to prevent leaks.
Additionally, an evaluation of diffusion
of gel through the implant shell is
required in 7.3.4.
Standard Clause 6.2 covers Directive
Annex I, ER 7.5 in respect of
cytotoxicity only.
Standard Clause 6.3 covers Directive
Essential Requirements Clause(s)/subclause(s) of
Remarks/Notes
of directive 93/42/EEC this EN
Annex I, ER 7.5 in respect of oligomers,
cyclotetrasiloxane (D4) and
cyclopentasiloxane (D5) only.
Standard Clause 6.4 covers Directive
Annex I, ER 7.5 in respect of the
specified metals and in production raw
materials only.
Standard Clause 7.2.2.1 covers
Directive Annex I, ER 7.5 in respect of
the integrity of the implant shell only.
9.2, second indent 7.2.2.2.2 The Essential Requirement is covered
with respect to a potential external
impact on the implant, e.g. due to the
safety belt being triggered in a car
accident.
The standard provides an impact
resistance test to make sure implants
withstand such impacts.
Standard Clause 7.2.2.2.2. covers
Directive Annex I, ER 9.2 second dash
in respect of impact resistance of the
device only.
13.1 11.3, Annex I, Annex J While the references to
ISO 14630:2012 in 11.3 point to useful
information, they are not considered
relevant within the context of this
Annex ZA.
Only the requirements provided
specifically in this standard should be
considered when claiming coverage of
the Essential Requirement with this
standard.
13.3 a) 11.7.2 a), c), Annex J a) Directive Annex I, ER 13.3 a) is
covered in respect of name or trade
name and address of the manufacturer
only. The requirement regarding the
name and address of authorized
representative is not covered.
Essential Requirements Clause(s)/subclause(s) of
Remarks/Notes
of directive 93/42/EEC this EN
13.3 b) 11.2 While the references to
ISO 14630:2012 in 11.2 point to useful
information, they are not considered
relevant within the context of this
Annex ZA.
Only the requirements provided
specifically in this standard, which
only partly cover the Essential
Requirement 13.3 b), should be
considered when claiming coverage of
the Essential Requirement with this
standard.
13.3 d) 11.7.2 b) —
13.3 j) 11.5, Annex I Standard Clause 11.5 covers Directive
Annex I, ER 13.3 i) in respect of filling
materials only.
Standard Annex I covers Directive
Annex I, ER 13.3 i) only in respect of
the aspects detailed in the standard.
13.3 k) Annex I The ER is covered only in respect of
the aspects detailed in the standard.
13.6.d) Annex I h) Standard Annex I h) covers Directive
Annex I, 13.6 d) provided the
information is in the instructions for
use.
13.6 e) 11.6, Annex J c), d), h) Standard Clause 11.6 and Annex J c)
and d) cover Directive Annex I, ER 13.6
e) only in respect of expected lifetime.
Standard Annex J h) covers Directive
Annex I, ER 13.6 e) only in respect of
possible effects on breast feeding.
13.6. f) 11.3.3, Annex J j), k), l), The ER is covered only in respect of
the aspects detailed in the standard.
13.6 l) Annex J l) Standard Annex J l) covers Directive
Annex I, 13.6 l) provided the
information is in the instructions for
use and is given to the patient.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of this
standard.
INTERNATIONAL ISO
STANDARD 14607
Third edition
2018-04
Corrected version
2018-08
Non-active surgical implants —
Mammary implants — Particular
requirements
Implants chirurgicaux non actifs — Implants mammaires —
Exigences particulières
Reference number
ISO 14607:2018(E)
©
ISO 2018
ISO 14607:2018(E)
© ISO 2018
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ISO 14607:2018(E)
Contents Page
Foreword .
...