National foreword

This British Standard is the UK implementation of EN ISO 14630:2024. It is identical to ISO 14630:2024. It supersedes BS EN ISO 14630:2012, which is withdrawn.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 December 2024.

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 fifth edition cancels and replaces the fourth edition (ISO 14630:2012), which has been technically revised.

The main changes are as follows:

the scope has been revised to clarify that this document does not apply to implants utilizing viable animal or human tissue;
definitions have been added for clinical evaluation and clinical investigation based on the International Medical Device Regulators Forum (IMDRF) guidance on clinical evaluation;
definitions have been added for demonstrably similar implant and reference implant to clarify when data for other implants can be used during pre-clinical and clinical evaluation of the implant under investigation;
indications, contraindications and target patient population have been added in Clause 4 to the list of factors to consider when establishing the intended performance of an implant;
reorganized list of design attributes in Clause 5 to put then in a more logical sequence;
revised Clause 6 on selection of material to use a risk analysis as the basis for selection of implant materials and to list factors to be taken into account when performing the risk analysis;
Clause 7 has been significantly expanded on design evaluation to address pre-clinical evaluation, clinical evaluation and investigation, and post-market surveillance in more detail;
Clause 8 has been expanded on manufacturing to address cleanliness of the implant;
subclause 9.1 has been revised to list the methods of sterilizing the implant in a tabular form rather than as running text;
a new subclause 10.3 has been added to address the determination of the use by date;
Clause 11 has been revised on information supplied by the manufacturer to include new subclauses addressing patient record labels (11.5) and implant card (11.6);
the subclause on restrictions on combinations (formerly 11.4) has been deleted because the safety of combinations is addressed in Clause 5 l).

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 standards dealing with non-active surgical implants and related instrumentation. For the implants themselves, they 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.

Level 1 standards include this document which contains requirements that apply to all non-active surgical implants, and ISO 16061, which contains requirement for instruments associated with non-active surgical implants. They also anticipate that there are additional requirements in the Level 2 and Level 3 standards.

Level 2 standards (see References [2], [12], [23], [27] and [42]) apply to a more restricted set or family of non-active surgical implants, such as those designed for use in neurosurgery, cardiovascular surgery or joint replacement.

Level 3 standards (see References [3], [13], [24] and [25]) apply to specific types of implants within a family of non-active surgical implants, such as hip joints or arterial stents.

To address the requirements for a specific implant, all related Level 1, 2 and 3 standards should be applied.

This European Standard was approved by CEN on 17 July 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 14630:2024) 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 June 2025, and conflicting national standards shall be withdrawn at the latest by June 2025.

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 14630:2012.

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 14630:2024 has been approved by CEN as EN ISO 14630:2024 without any modification.

1 Scope

This document specifies general requirements for non-active surgical implants, hereafter referred to as implants.

This document is not applicable to dental implants, dental restorative materials, transendodontic and transradicular implants, intra-ocular lenses and implants utilizing viable animal or human tissue.

With regard to safety, this document specifies requirements for intended performance, design attributes, materials, design evaluation, manufacture, sterilization, packaging and information supplied by the manufacturer, and tests to demonstrate compliance with these requirements.

Additional requirements applicable to specific implants or implant families are given or referred to in Level 2 and Level 3 standards.

NOTE 1 This document does not require that the manufacturer have a quality management system in place. However, many regulatory authorities require the application of a quality management system, such as that described in ISO 13485, to ensure that the implant achieves its intended performance and safety.

NOTE 2 In this document, when not otherwise specified, the term "implant" refers to each individual component of a system or a modular implant, provided separately or as a set of components, as well as to all ancillary implants or associated implants designed for improving the intended performance.

2 Normative references

3 Terms and definitions

4 Intended performance

5 Design attributes

6 Selection of materials

7 Design evaluation

7.1 General

7.2 Pre-clinical evaluation

7.3 Clinical evaluation and clinical investigation

7.4 Post-market surveillance

8 Manufacture

9 Sterilization

9.1 Implants supplied sterile

9.2 Implants supplied non-sterile

9.3 Re-sterilizable implants

9.4 Sterilization residuals

10 Packaging

10.1 Protection from damage in transport, storage and handling

10.2 Maintenance of sterility in transport, storage and handling

10.3 Use by date

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 Implant card

11.7 Implants for special purposes

Bibliography

BS EN ISO 14630:2024

Non-active surgical implants. General requirements

Current

Published:

31 Dec 2024