EN ISO 14607:2018

SLOVENSKI STANDARD
01-julij-2018
1DGRPHãþD
SIST EN ISO 14607:2009
Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO
14607:2018)
Non-active surgical implants - Mammary implants - Particular requirements (ISO
14607:2018)
Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen
(ISO 14607:2018)
Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières (ISO
14607:2018)
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)
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.

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
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

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 has been approved by CEN as EN ISO 14607:2018 without any modification.

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
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
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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Published in Switzerland
ii © ISO 2018 – All rights reserved

ISO 14607:2018(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Intended performance . 3
5 Design attributes . 3
6 Materials . 3
6.1 General . 3
6.2 Cytotoxicity . 4
6.3 Residual low molecular weight oligomers . 4
6.4 Trace elements . 4
6.5 Physico-mechanical properties and characterization . 4
6.6 Documentation of materials . 4
7 Design evaluation . 5
7.1 General . 5
7.2 Pre-clinical evaluation . 5
7.2.1 General. 5
7.2.2 Mechanical tests . 5
7.2.3 Physical evaluation . 6
7.2.4 Chemical evaluation . 7
7.2.5 Biological evaluation . 7
7.3 Clinical evaluation . 7
7.4 Post-market surveillance . 7
8 Manufacturing . 7
9 Sterilization . 7
10 Packaging . 7
11 Information supplied by the manufacturer . 8
11.1 General . 8
11.2 Product labelling . 8
11.3 Information for the user . 8
11.3.1 General. 8
11.3.2 Resterilization . 8
11.3.3 Effects on diagnostic techniques . 8
11.4 Marking on implants . 8
11.5 Filling materials . 8
11.6 Information on expected lifetime . 8
11.7 Information for the patient . 9
11.7.1 General. 9
11.7.2 Patient record label . 9
11.7.3 Patient card . . . 9
Annex A (normative) Determination of octamethylcyclotetrasiloxane (D4) and
decamethylcyclopentasiloxane (D5) in silicone gels .10
Annex B (normative) Tests for shell integrity .14
Annex C (normative) Mechanical tests on a mammary implant in its implantable state .17
Annex D (normative) Test method for valve competence and injection site competence .23
Annex E (normative) Test for silicone gel cohesion (silicone filling materials only) .25
ISO 14607:2018(E)
Annex F (normative) Test for silicone gel penetration (silicone filling materials only) .27
Annex G (informative) Assessment of silicone diffusion from mammary implants using an
in vitro method .32
Annex H (informative) Test for surface characteristics .36
Annex I (normative) Information for the user .39
Annex J (normative) Information for the patient .40
Bibliography .41
iv © ISO 2018 – All rights reserved

ISO 14607:2018(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 non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 150, Implants for surgery,
This third edition cancels and replaces the second edition (ISO 14607:2007), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— limit values for trace elements have been added (6.4);
— determination of octamethylcyclotetrasiloxane (D4) and decamethylcyclopentasiloxane (D5) in
silicone gels (new Annex A) has been included;
— mechanical test on a mammary implant in its implantable state (new Annex C, previously Annex E),
specifically the fatigue test (C.1), has undergone major revision;
— test for silicone gel penetration (silicone filling materials only) (new Annex F) has been included;
— silicone diffusion assessment from mammary implants by an in vitro method (new Annex G,
previously Annex H) has undergone major revision;
— test for surface characteristics (new Annex H, previously Annex A) has undergone major revision.
ISO 14607:2018(E)
Introduction
There are three levels of International Standards dealing with non-active surgical implants. These are
as follows (with level 1 being the highest):
— Level 1: General requirements for non-active surgical implants;
— Level 2: Particular requirements for families of non-active surgical implants;
— Level 3: Specific requirements for types of non-active surgical implants.
This document is a level 2 standard and contains particular requirements for a family of mammary
implants.
The level 1 standard, ISO 14630, contains requirements that apply to all non-active surgical implants. It
also indicates that there are additional requirements in the level 2 and level 3 standards.
To address all requirements, the lowest available level is the level to start with.
vi © ISO 2018 – All rights reserved

INTERNATIONAL STANDARD ISO 14607:2018(E)
Non-active surgical implants — Mammary implants —
Particular requirements
1 Scope
This document specifies particular requirements for mammary implants.
With regard to safety, this document specifies requirements for intended performance, design
attributes, materials, design evaluation, manufacturing, packaging, sterilization, and information
supplied by the manufacturer.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 34-1:2015, Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser,
angle and crescent test pieces
ISO 37:2017, Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
ISO 4287, Geometrical Product Specifications (GPS) — Surface texture: Profile method — Terms, definitions
and surface texture parameters
ISO 7619-1, Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1:
Durometer method (Shore hardness)
ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-18, Biological evaluation of medical devices — Part 18: Chemical characterization of materials
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 14155, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14630:2012, Non-active surgical implants — General requirements
ASTM D412−16, Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers — Tension
ASTM D624−00 (2012), Standard guide for evaluation of thermoplastic polyurethane solids and solutions
for biomedical applications
ASTM D792−13, Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by
Displacement
ASTM D2240−15, Standard Test Method for Rubber Property — Durometer Hardness
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 10993-1, ISO 14155 and
ISO 14630 and the following apply.
ISO 14607:2018(E)
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http: //www .electropedia .org/
— ISO Online browsing platform: available at https: //www .iso .org/obp
3.1
anterior projection
maximum height of the implant when placed with its base on a flat horizontal surface
Note 1 to entry: For inflatable and adjustable implants, this applies to the implant's nominal volume.
3.2
base dimension
length of the major axis and the length of the minor axis when the implant is placed with its base on a
flat horizontal surface
Note 1 to entry: For inflatable and adjustable implants, this applies to the implant's nominal volume.
3.3
cure
process of transforming uncured polymer into an elastic material through a covalent crosslinking
reaction
3.4
diffusion
movement of material in and/or out of an implant through an intact shell
3.5
filling volume
volume of the material contained within the shell or volume of the solution necessary to fill an inflatable
or adjustable mammary implant
3.6
implant volume
volume of the shell and filler material together
3.7
injection site
component designed to be penetrated by a needle to alter the volume of the implant
3.8
mammary implant
implant with a shell which has been filled by the manufacturer (3.9) or is designed to be filled by the
surgeon, and is intended to add or replace volume of the breast
3.9
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging and labelling of a
device before it is placed on the market under his own name, regardless of whether these operations
are carried out by that person himself or on his behalf by a third party
[SOURCE: ISO 10993-18:2005, 3.2]
3.10
orientation means
mark in or on the implant to assist the surgeon in positioning the implant
2 © ISO 2018 – All rights reserved

ISO 14607:2018(E)
3.11
shell
envelope of the mammary implant (3.8)
3.12
seam
seal junction of implant materials fused or adhered together
3.13
silicone elastomer
synthetic rubber obtained by the crosslinking of silica reinforced silicone polymer chains essentially
made of repeat diorganosiloxane units
3.14
silicone gel
partially crosslinked silicone polymer, featuring a semisolid material consisting of crosslinked silicone
polymer and liquid silicone polymer [silicone oil or polydimethylsiloxane (PDMS)])
3.15
silicone polymer
polymer chains essentially made of repeat diorganosiloxane units
3.16
supplier
company who manufactures and/or supplies the raw materials and components used for the production
of mammary implants
3.17
tensile set
tensile elongation remaining after a specimen has been stretched and allowed to relax in a
controlled manner
3.18
valve
shell component allowing inflation of mammary implant with variable volumes of liquids when needed
and providing a tight closure the rest of the time
4 Intended performance
The requirements of ISO 14630:2012, Clause 4, shall apply.
5 Design attributes
The requirements of ISO 14630:2012, Clause 5, shall apply.
6 Materials
6.1 General
The requirements of ISO 14630:2012, Clause 6, shall apply.
Materials shall be manufactured and tested under a quality management system.
The information stated within Clause 6 shall be available from the manufacturer.
NOTE This information can typically be obtained from the raw material supplier.
When other materials than silicone are used, the manufacturer shall establish suitable test methods
and acceptance criteria to demonstrate the appropriate performance and safety of the implant.
ISO 14607:2018(E)
6.2 Cytotoxicity
The components of each production raw material lot shall be cured and tested for cytotoxicity in
accordance with ISO 10993-5. No cytotoxic effects, as defined in ISO 10993-5, shall be induced by the
material tested, or throughout the culture.
6.3 Residual low molecular weight oligomers
The combined residual oligomers, cyclotetrasiloxane (D4) and cyclopentasiloxane (D5), in uncured or
cured gel shall be tested in accordance with Annex A.
6.4 Trace elements
The components of each production raw material lot shall be in accordance with the Table 1
specifications on metal impurities.
Table 1 — Metals impurities limit content
Content limit per element
Element
(mg/kg)
As, Pb, Cd, Hg, V, Mo, Se, Co, Sb, Ba, Cr, Cu, Sn, Ni ≤10
If one of these metals comprises part of the formulation component (for example BaSO ), it is not
considered an impurity, and shall be considered for the biological evaluation of the implant.
6.5 Physico-mechanical properties and characterization
The following mechanical characteristics of silicone elastomers, after cure, shall be available for every
raw material lot:
— elongation at break (%), according to ISO 37:2017 or ASTM D412-16
— tensile strength at break (MPa) according to ISO 37:2017 or ASTM D412-16
— modulus at 100 % elongation (MPa), according to ISO 37; 2017 or ASTM D412-16
— hardness (IRHD), according to ASTM D2240-15 or ISO 7619-1
— relative density, or specific gravity, according to ASTM D792-13
— tear strength (kN/m), according to ISO 34-1:2015, Method C, or ASTM D624-00 (2012), Die B.
The penetration or bulk gel hardness of silicone gel, after cure, shall be available for every raw
material lot.
6.6 Documentation of materials
The manufacturer shall require from the supplier for each type of material, a certificate of analysis
including at least the following information:
a) supplier’s name, address and telephone number;
b) material reference;
c) for silicone material the range of properties (as defined in 6.5), with defined specification limits
and test methods, including cure conditions. For other materials, same type of information shall be
required, if applicable.
4 © ISO 2018 – All rights reserved

ISO 14607:2018(E)
7 Design evaluation
7.1 General
The requirements of ISO 14630:2012, 7.1, shall apply.
The design of mammary implants shall be based on a risk assessment taking into account the fact that
their benefit is deemed to be primarily aesthetic and psychological in nature, whether the application is
for reconstructive and/or cosmetic purposes.
7.2 Pre-clinical evaluation
7.2.1 General
The pre-clinical evaluation of mammary implants shall conform to ISO 14630:2012, 7.2, and fulfil the
requirements of ISO 10993-1.
The texture of the breast implant shell is to be taken into account when demonstrating biocompatibility.
Extrapolation of biocompatibility data for smooth breast implants is not sufficient for demonstrating
the biocompatibility of textured breast implants.
Where no test is described in this document, or when the test described is not applicable, description
for the alternative validated test method, test specimen preparation used and test results shall be
documented by the manufacturer. The adequacy of the pass/fail criteria adopted for the evaluation
shall be verified prior to testing.
All testing samples shall be representative of finished sterilized devices.
A worst-case assumption shall be considered.
The sample size selected shall be based on a statistical rationale, which shall be justified and
documented. Where appropriate, for materials other than silicone, the manufacturer shall consider and
develop tests as indicated in 7.2.2 to 7.2.5.
7.2.2 Mechanical tests
7.2.2.1 Shell integrity
7.2.2.1.1 General
The integrity of the shell shall be evaluated.
The following properties of the silicone elastomer shell shall be tested in accordance with Annex B.
7.2.2.1.2 Elongation
The elongation of the silicone elastomer shell shall be tested in accordance with B.1.2.
7.2.2.1.3 Tensile set
The tensile set of the silicone elastomer shell shall be tested in accordance with B.1.3.
7.2.2.1.4 Strength of joints, seams or seals
The resistance to failure of joints, seams and seals shall be tested in accordance with B.2
ISO 14607:2018(E)
7.2.2.2 Implant resistance
7.2.2.2.1 Fatigue resistance test
The fatigue resistance test shall be conducted in accordance with C.1.
7.2.2.2.2 Impact resistance test
The impact resistance test shall be conducted in accordance with C.2.
7.2.3 Physical evaluation
7.2.3.1 Design of shell
Surfaces both inside and outside of the shell shall be suitable to minimize frictional abrasion both
between shell-to-shell surface and between shell surface and the implantation site. If such frictional
abrasion is likely to be a significant problem, the manufacturer shall indicate any relevant tests carried
out to ensure the suitability of the shell when implanted.
7.2.3.2 Valve or injection site competence
The competence of the valve or injection site shall be tested in accordance with Annex D.
7.2.3.3 Filling material
7.2.3.3.1 General
The physical compatibility between the filling material and the shell shall be demonstrated by providing
long-term data on shell performance and integrity.
7.2.3.3.2 Silicone gel cohesion
If silicone gel is used as filling material, cohesivity testing shall be performed in accordance with
Annex E.
7.2.3.3.3 Silicone gel penetration
Penetration of silicone gel shall be evaluated. Testing to verify if specifications are met shall be
performed in accordance with Annex F.
NOTE It is not possible to perform this test on a finished device. Therefore, it is usually performed as a
process control (see F.1).
7.2.3.4 Diffusion test
Diffusion from the whole implant shall be evaluated.
NOTE There are currently two test methods described in Annex G and ASTM F703-18 that might provide
some valuable information concerning the diffusion. These two methods are given as examples but are not
mandatory.
7.2.3.5 Volume
The volume of the implants filled by the manufacturer shall be within ±2,5 % of the implant volume
stated on the labelling.
6 © ISO 2018 – All rights reserved

ISO 14607:2018(E)
7.2.3.6 Dimensions
The actual device base dimensions and anterior projection shall be measured and recorded.
7.2.3.7 Surface
If the surface is specially treated or processed in order to form a specific texture, the surface
characteristics shall be assessed and the test results shall be recorded.
Annex H can be used as a guide.
7.2.3.8 Surface contamination
The manufacturer shall conduct a risk assessment to define appropriate limits for particulate
contamination of the surface of the finished mammary implant.
7.2.4 Chemical evaluation
Each shell, filler material and, if applicable, coating material shall be chemically evaluated in accordance
with ISO 10993-18.
7.2.5 Biological evaluation
The implant shall be evaluated in accordance with the requirements of ISO 10993-1, within a risk
management process.
7.3 Clinical evaluation
The requirements of ISO 14630:2012, 7.3, shall apply.
The purpose of the clinical evaluation is to estimate the frequency and rate at which complications
occur, e.g. capsular contracture and ruptures/deflation of implants, after implantation of a mammary
implant.
7.4 Post-market surveillance
The requirements of ISO 14630:2012, 7.4, shall apply.
8 Manufacturing
The requirements of ISO 14630:2012, Clause 8, shall apply.
9 Sterilization
The requirements of ISO 14630:2012, 9.1, 9.2 and 9.4, shall apply.
Implants shall be supplied sterile.
10 Packaging
The requirements of ISO 14630:2012, Clause 10, apply.
Packaging design shall be validated according to ISO 11607-1.
ISO 14607:2018(E)
11 Information supplied by the manufacturer
11.1 General
The requirements of ISO 14630:2012, 11.1, shall apply.
The information shall be supplied by the manufacturer on the label, package insert or any other media
(e.g. user manual, patient information).
NOTE Information supplied by the manufacturer can be subject to national or regional regulations.
11.2 Product labelling
The requirements of ISO 14630:2012, 11.2, shall apply.
Additionally, the labelling shall include the following details necessary for identification of the implant:
a) implant dimensions (base dimensions, anterior projection and implant volume), and
b) filling volume, for inflatable or adjustable mammary implant.
11.3 Information for the user
11.3.1 General
The requirements of ISO 14630:2012, 11.3, shall apply.
The manufacturer shall provide the user with the information, as specified in Annex I.
11.3.2 Resterilization
The requirements of ISO 14630:2012, 9.3.2, shall apply.
11.3.3 Effects on diagnostic techniques
The effect of the implant on diagnostic techniques, such as mammography or magnetic resonance
imaging (MRI), shall be provided to the user.
11.4 Marking on implants
In addition to the requirements of ISO 14630:2012, 11.5, the implant volume shall be indicated on the
implant.
11.5 Filling materials
For inflatable and adjustable implants, the manufacturer shall indicate the filling materials and filling
instructions.
11.6 Information on expected lifetime
The manufacturer shall provide information on the expected duration of performance of the device
as intended, prefe
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