National foreword

This British Standard is the UK implementation of EN ISO 14607:2025. It is identical to ISO 14607:2024. It supersedes BS EN ISO 14607:2018, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/150, Implants for surgery.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

This publication has been prepared under a mandate given to the European Standards Organizations by the European Commission and the European Free Trade Association. It is intended to support requirements of the EU legislation detailed in the European Foreword. A European Annex, usually Annex ZA or ZZ, describes how this publication relates to that EU legislation.

For the Great Britain market (England, Scotland and Wales), if UK Government has designated this publication for conformity with UKCA marking (or similar) legislation, it may contain an additional National Annex. Where such a National Annex exists, it shows the correlation between this publication and the relevant UK legislation. If there is no National Annex of this kind, the relevant Annex ZA or ZZ in the body of the European text will indicate the relationship to UK regulation applicable in Great Britain. References to EU legislation may need to be read in accordance with the UK designation and the applicable UK law. Further information on designated standards can be found at www.bsigroup.com/standardsandregulation.

For the Northern Ireland market, UK law will continue to implement relevant EU law subject to periodic confirmation. Therefore Annex ZA/ZZ in the European text, and references to EU legislation, are still valid for this market.

UK Government is responsible for legislation. For information on legislation and policies relating to that legislation, consult the relevant pages of www.gov.uk.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 August 2025.

This European Standard was approved by CEN on 17 October 2024.

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, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

European foreword

This document (EN ISO 14607:2025) 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 February 2026, and conflicting national standards shall be withdrawn at the latest by February 2026.

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 14607:2018.

This document has been prepared under a standardization request addressed to CEN by the European Commission. The Standing Committee of the EFTA States subsequently approves these requests for its Member States.

For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this document.

Any feedback and questions on this document should be directed to the users’ national standards body/national committee. A complete listing of these bodies can be found on the CEN website.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United Kingdom.

Endorsement notice

The text of ISO 14607:2024 has been approved by CEN as EN ISO 14607:2025 without any modification.

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 document 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).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of 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 www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 285, Non-active surgical implants, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This fourth edition cancels and replaces the third edition (ISO 14607:2018), which has been technically revised.

The main changes are as follows:

trace elements subclause (6.4) has been revised;
language regarding biological evaluation and risk management has been revised and expanded in the general part of the pre-clinical evaluation subclause (7.2.1);
contamination subclause has been renamed to particulate contamination (7.2.3.8) and completely revised;
requirements regarding implantation studies have been added (7.2.5);
clinical evaluation requirements have been expanded (7.3);
surface category has been added to the label requirements (11.3);
Annex C “Mechanical tests on a mammary implant in its implantable state” has been expanded and revised;
the fatigue resistance testing method (Clauses C.1 and C.3) has been revised and expanded;
Annex F “Test for silicone gel penetration (silicone filling materials only)” has been re-structured and the language has been clarified;
Annex G “Assessment of silicone diffusion from mammary implants using an in vitro method” has been deleted as the test method given in the annex did not accomplish its purpose;
Annex H “Test for surface characteristics” has been re-numbered as Annex G and has been renamed “Surface classification”, its status has been changed to normative, it has completely revised and an expanded surface classification has been added;
Annex J “Tests for surface particulate contamination” has been newly added;
the language of test report subclauses in all annexes has been harmonized as much as possible.

Any feedback or questions on this document should be directed to the user’s national standards body. A complete listing of these bodies can be found at www.iso.org/members.html.

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 3 standard and contains specific requirements for 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.

1 Scope

This document specifies specific 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

3 Terms and definitions

4 Intended performance

5 Design attributes

6 Materials

6.1 General

6.2 Cytotoxicity

6.3 Silicone gel residual low molecular weight oligomers

6.4 Trace elements

6.5 Physico-mechanical properties and characterization

6.6 Documentation of materials

7 Design evaluation

7.1 General

7.2 Pre-clinical evaluation

7.3 Clinical evaluation

7.4 Post-market surveillance

8 Manufacturing

8.1 General

9 Sterilization

10 Packaging

11 Information supplied by the manufacturer

11.1 General

11.2 Marking on implants

11.3 Label

11.4 Instructions for use

11.5 Patient record label(s)

11.6 Additional information for the user

11.7 Information on expected lifetime

11.8 Information for the patient

Bibliography

BS EN ISO 14607:2025

Non-active surgical implants. Mammary implants. Specific requirements

Current

Published:

31 Aug 2025