National foreword

This British Standard is the UK implementation of ISO 5092:2025.

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.

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 30 September 2025.

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 Technical Committee ISO/TC 261, Additive manufacturing.

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

This document is intended to provide information and guidance for designing implants and adapting additive manufacturing (AM) techniques for surgical implant applications. This document is also intended to provide information and guidance to experts drafting specific standards on implants or AM techniques for surgical implant applications. This information and guidance are particularly intended to be useful for implant manufacturers and regulatory authorities, but can also be useful for other stakeholders.

The references detailed in this document do not constitute an exhaustive list of documents that can be useful to users of this document.

1 Scope

This document identifies factors that affect the safety and performance of surgical implants due to the fact that these implants are manufactured additively.

This document applies to non-active implants manufactured additively, including custom-made implants and patient-matched implants.

This document also applies to instrumentation for use in association with non-active surgical implants manufactured by additive manufacturing (AM).

While this document is not intended to apply to active implants, certain clauses or subclauses of this document can potentially still be used in the context of active implants.

This document identifies factors which are either unique to additively manufactured implants or which require additional consideration for additively manufactured implants. These factors have not always been included within existing implant specific standards.

This document is not applicable to implants which contain or incorporate tissues or cells, or their derivates, of animal or human origin.

2 Normative references

3 Terms and definitions

4 Relevance of additive manufacturing techniques

5 Risk analysis — Dedicated to implants in AM

5.1 General

5.2 Data processing

5.3 Feedstock material

5.4 AM process and post-processing

5.5 Cleanliness and sterilization

6 Materials

6.1 General

6.2 Feedstock characteristics

6.3 Feedstock reuse

7 Design for AM implants

8 Qualification and validation of AM processes

Bibliography

BS ISO 5092:2025

Additive manufacturing for medical. General principles. Additive manufacturing of non-active implants

Current

Published:

30 Sep 2025