Non-active surgical implants - Mammary implants - Particular requirements (ISO 14607:2018)

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.

Nichtaktive chirurgische Implantate - Mammaimplantate - Besondere Anforderungen (ISO 14607:2018)

Dieses Dokument legt besondere Anforderungen an Mammaimplantate fest.
Im Hinblick auf die Sicherheit legt dieses Dokument Anforderungen an die beabsichtigte Funktion, Konstruktionsmerkmale, Werkstoffe, Designbewertung, Herstellung, Verpackung, Sterilisation und vom Hersteller zu liefernde Informationen fest.

Implants chirurgicaux non actifs - Implants mammaires - Exigences particulières (ISO 14607:2018)

L'ISO 14607:2018 spécifie les exigences particulières relatives aux implants mammaires.
En matière de sécurité, le présent document spécifie des exigences relatives aux performances prévues, aux caractéristiques de conception, aux matériaux, à l'évaluation de la conception, à la fabrication, à l'emballage, à la stérilisation et aux informations fournies par le fabricant.

Neaktivni kirurški vsadki (implantati) - Prsni vsadki - Posebne zahteve (ISO 14607:2018)

Ta dokument določa posebne zahteve za prsne vsadke.
V zvezi z varnostjo ta standard določa zahteve za predvideno zmogljivost, obliko, materiale, vrednotenje oblike, izdelavo, pakiranje, sterilizacijo in informacije, ki jih zagotovi proizvajalec.

General Information

Status
Published
Public Enquiry End Date
19-Jun-2017
Publication Date
12-Jun-2018
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
30-May-2018
Due Date
04-Aug-2018
Completion Date
13-Jun-2018

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SLOVENSKI STANDARD
SIST EN ISO 14607:2018
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
SIST EN ISO 14607:2018 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 14607:2018
---------------------- Page: 2 ----------------------
SIST EN ISO 14607:2018
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.
---------------------- Page: 3 ----------------------
SIST EN ISO 14607:2018
EN ISO 14607:2018 (E)
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

---------------------- Page: 4 ----------------------
SIST EN ISO 14607:2018
EN ISO 14607:2018 (E)
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
---------------------- Page: 5 ----------------------
SIST EN ISO 14607:2018
EN ISO 14607:2018 (E)
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.

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SIST EN ISO 14607:2018
EN ISO 14607:2018 (E)
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
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SIST EN ISO 14607:2018
EN ISO 14607:2018 (E)
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.
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SIST EN ISO 14607:2018
EN ISO 14607:2018 (E)
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.
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SIST EN ISO 14607:2018
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SIST EN ISO 14607:2018
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
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SIST EN ISO 14607:2018
ISO 14607:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
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SIST EN ISO 14607:2018
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 2018 – All rights reserved iii
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SIST EN ISO 14607:2018
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
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SIST EN ISO 14607:2018
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 2018 – All rights reserved v
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SIST EN ISO 14607:2018
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
---------------------- Page: 16 ----------------------
SIST EN ISO 14607:2018
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 ther
...

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