ISO 11979-9-2006 PDF

Full title and description

Ophthalmic implants — Intraocular lenses — Part 9: Multifocal intraocular lenses (ISO 11979-9:2006). This part of ISO 11979 provides requirements and guidance specific to intraocular lens (IOL) optics that provide two or more rotationally symmetric powers intended to give useful vision at more than one distance (e.g., far and near).

Abstract

ISO 11979-9:2006 is applicable to multifocal intraocular lenses whose optic provides two or more rotationally symmetric powers and whose primary indication is correction of aphakia with the added benefit of useful vision at multiple distances (including near and/or intermediate distances). It sets out scope, general requirements and test/assessment topics relevant to multifocal IOLs.

General information

• Status: Withdrawn / no longer current as published in 2006; later revisions of the ISO 11979 series incorporated multifocal IOL considerations.
• Publication date: 4 September 2006 (Edition 1, 2006).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.70 (Ophthalmic optics and instruments).
• Edition / version: Edition 1 (2006).
• Number of pages: 20 pages (as published).

Scope

This part of ISO 11979 applies specifically to intraocular lenses that provide two or more rotationally symmetric optical powers (multifocal IOLs) intended primarily for correction of aphakia while providing useful vision at multiple distances (far, near and/or intermediate). The document describes the intended applicability rather than providing exhaustive test procedures for every device type.

Key topics and requirements

• Definition and identification of multifocal intraocular lenses and their intended performance claims.
• General design and performance considerations relevant to multifocal optics (optical power distribution, intended focal distances).
• Requirements for documentation, labelling and claims regarding distances of useful vision.
• Reference to appropriate optical and clinical assessment approaches for demonstrating performance and safety (to be aligned with other parts of ISO 11979 series).
• Notes on terminology (how "near" and "intermediate" are used within the part).

Typical use and users

Primary users include IOL manufacturers (design, testing and regulatory documentation), conformity assessment bodies, test laboratories performing optical/functional evaluations, and regulatory or clinical professionals interpreting device claims. The standard was intended to be used alongside other parts of ISO 11979 that cover optical test methods, mechanical properties, biocompatibility and clinical investigation requirements.

Related standards

ISO 11979-9 is one part of the ISO 11979 series on intraocular lenses. Related parts include ISO 11979-1 (vocabulary), -2 (optical properties and test methods), -3 (mechanical properties and test methods), -4 (labelling and information), -5 (biocompatibility), -6 (shelf-life and transport stability), -7 (clinical investigations), -8 (fundamental requirements), and -10 (phakic IOLs). Users should consult the relevant parts for complete requirements and test methods.

Keywords

multifocal intraocular lens, IOL, ophthalmic implants, multifocal optics, aphakia, optical performance, ISO 11979, labelling, clinical investigation.

FAQ

Q: What is this standard?

A: ISO 11979-9:2006 is the part of the ISO 11979 series titled "Multifocal intraocular lenses" that provided requirements and guidance specific to IOL optics offering multiple powers.

Q: What does it cover?

A: It covers the applicability, definitions and general requirements for multifocal IOLs (IOLs with two or more rotationally symmetric powers), and refers users to other parts of ISO 11979 for detailed optical, mechanical, biocompatibility and clinical test methods.

Q: Who typically uses it?

A: IOL manufacturers, test laboratories, regulatory authorities and clinical investigators use the standard as part of product development, testing and conformity documentation.

Q: Is it current or superseded?

A: ISO 11979-9:2006 has been withdrawn; multifocal-IOL topics have been incorporated into later revisions of the ISO 11979 series and related parts (the series and Part 7 revisions in subsequent years consolidated and updated clinical and device-specific requirements). Consult the current editions of ISO 11979 parts for up-to-date requirements.

Q: Is it part of a series?

A: Yes — it is part of the ISO 11979 series addressing intraocular lenses (multiple parts cover vocabulary, optical/mechanical/biocompatibility tests, labelling, clinical investigations and specific device categories).

Q: What are the key keywords?

A: Multifocal IOL, intraocular lens, aphakia correction, optical powers, ISO 11979, ophthalmic implants.