National foreword

This British Standard is the UK implementation of EN ISO 16671:2025. It is identical to ISO 16671:2025. It supersedes BS EN ISO 16671:2015+A1:2017, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/172/7, Eye implants.

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 June 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 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 170, Ophthalmic optics, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This third edition cancels and replaces the second edition (ISO 16671:2015), which has been technically revised. It also incorporates the Amendment ISO 16671:2015/Amd.1:2017.

The main changes are as follows:

Inclusion of applicable sections from ISO 14630 throughout the document and removal of any reference to that standard. It was further clarified that ophthalmic irrigation solutions (OIS) are not implants by their intended use but are likely to share some of the risks related to non-active implants. Therefore, the following clauses and subclauses have been revised: Clause 4, Clause 5, Clause 7 and 9.1;
Clarifications of terms 3.1, 3.2, 3.3 and 3.4;
Revision of 5.1 for a more accurate description of design attributes;
Revision of Clause 7 to clarify the risks associated with components of OIS sterilized by ethylene oxide (EO);
Revision of Clause 8 to clarify that the real time shelf-life testing shall be performed and the accelerated shelf-life testing is optional;
Revision of Annex E to provide additional clarification regarding the number of test and control eyes enrolled in the study and that use of medication during the study that could possibly impact the study results;
Annex F was changed from informative to normative and clarified that the same intraocular surgical procedure is performed in the test and control arms and changed the first post-operative intraocular pressure (IOP) measurement from 6 h ± 2 h to 8 h ± 2 h to capture the effect of irrigation solution on IOP and align it with ISO 15798:2022, F.2;
Inclusion of Annex G;
The example for patient number calculation is incorporated into Annex H;
Correction of Formulae H.1 and H.2.

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.

This European Standard was approved by CEN on 16 June 2025.

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 16671:2025) has been prepared by Technical Committee ISO/TC 172 "Optics and photonics" in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” 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 December 2025, and conflicting national standards shall be withdrawn at the latest by December 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 16671:2015.

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 16671:2025 has been approved by CEN as EN ISO 16671:2025 without any modification.

1 Scope

This document defines requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.

This document applies to ophthalmic irrigating solutions (OIS), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic function.

2 Normative references

3 Terms and definitions

4 Intended performance

5 Design attributes

5.1 General

5.2 Chemical description and contaminants

5.3 Water used

5.4 Characterization of the finished product

6 Design evaluation

6.1 General

6.2 Evaluation of biological safety

6.3 Clinical evaluation

7 Sterilization

8 Product stability

9 Packaging

9.1 Protection from damage during storage and transport

9.2 Maintenance of sterility in transit and storage

10 Information supplied by the manufacturer

Bibliography

BS EN ISO 16671:2025

Ophthalmic implants. Irrigating solutions for ophthalmic surgery

Current

Published:

30 Jun 2025