ISO 11979-7:2024 眼科用インプラント | ページ 2

3.1 用語と定義

この文書の目的としては、ISO 11979-1 および ISO 14155 に記載されている用語と定義が適用されます。

ISO と IEC は、標準化に使用する用語データベースを次のアドレスで維持しています。

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.

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.

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

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

3 Terms and definitions and abbreviated terms

3.2 Abbreviated terms

Bibliography