National foreword

This British Standard is the UK implementation of EN ISO 11979‑7:2024. It is identical to ISO 11979‑7:2024. It supersedes BS EN ISO 11979‑7:2018, which is withdrawn.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.

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 fifth edition cancels and replaces the fourth edition (ISO 11979‑7:2018), which has been technically revised. The changes related herein for updating the document to the fifth edition apply to devices that will enter the marketplace after the date of publication of the fifth edition and are not designed or meant to limit any devices currently approved and marketed, nor those devices in the process of approval.

The main changes are as follows:

development of definitions of non-accommodative posterior chamber “Simultaneous Vision Range” (SVIOL) lenses that include the subtypes of MIOL (Multifocal), EDF (Extended Depth of Focus) and FVR (Full Visual Range) IOLs, and defining each of these IOL types to allow differentiation among the lens types based on clinical and safety performance measures;
establishment of guidelines for clinical testing of newly defined IOL types as listed above as well as related novel lens types, with alignment of testing methodologies among the lens types;
ISO 11979‑1, ISO 11979‑2, ISO 11979‑4 and ISO/TR 22979 are under revision and, when published, will be aligned with this edition of ISO 11979‑7.

A list of all parts in the ISO 11979 series can be found on the ISO website.

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

Intraocular lenses (IOLs) are used to correct residual refractive errors in subjects who have aphakia. Such residual refractive errors typically include sphere and astigmatism but may also correct for a lack of accommodation. Different designs of IOLs can be used to correct for specific refractive errors. In the case where an IOL is designed to provide more than one type of refractive correction, that IOL will have to satisfy each of the separate requirements of those correction designs.

This document provides requirements and recommendations for intraocular lens investigations of new IOL models. In the case where an IOL model is a modification of a parent IOL model, a risk analysis can be used in order to determine the appropriate level of testing.

This European Standard was approved by CEN on 19 January 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, 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 United Kingdom.

European foreword

This document (EN ISO 11979‑7:2024) 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 July 2024, and conflicting national standards shall be withdrawn at the latest by July 2024.

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 11979‑7:2018.

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 11979‑7:2024 has been approved by CEN as EN ISO 11979‑7:2024 without any modification.

1 Scope

This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.

2 Normative references

3 Terms and definitions and abbreviated terms

3.1 Terms and definitions

3.2 Abbreviated terms

4 Justification for a clinical investigation

5 Ethical considerations

6 General requirements

6.1 General

6.2 Design of a clinical investigation

6.3 Characteristics of clinical investigations

6.4 Duration of the investigations

6.5 Enrolment

6.6 Bilateral implantation

6.7 Surgical technique

6.8 Examination and treatment of subjects

6.9 Adverse events reports

6.10 Inclusion and exclusion criteria

Bibliography

BS EN ISO 11979-7:2024

Ophthalmic implants. Intraocular lenses - Clinical investigations of intraocular lenses for the correction of aphakia

Current

Published:

31 Jan 2024