ISO 11979-2-2024 PDF

Full title and description

Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods (ISO 11979-2:2024). This international standard specifies requirements and standardized test methods for measuring and reporting selected optical properties of intraocular lenses (IOLs), including monofocal, toric, simultaneous-vision and accommodative optics. The generic descriptor “IOL” used in the document also covers phakic intraocular lenses (PIOLs).

Abstract

ISO 11979-2:2024 defines the optical performance characteristics and the laboratory test procedures used to evaluate intraocular lenses. It establishes accepted units, definitions, measurement techniques and minimum reporting information for properties such as optical power, focal length, image quality metrics and toric axis orientation. The standard is intended to ensure consistent, comparable optical data for design verification, regulatory submissions and quality control.

General information

• Status: Published (current)
• Publication date: 31 October 2024
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.70 (Ophthalmic instruments and implants)
• Edition / version: Edition 3 (2024)
• Number of pages: 22

Scope

This part of ISO 11979 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with monofocal, toric, simultaneous-vision and/or accommodative optics. It provides definitions, measurement conditions and acceptance/reporting formats for optical power, focal length, imaging performance and related optical characteristics. The scope includes phakic IOLs where applicable and is intended for use in laboratory evaluation, design verification and regulatory performance documentation.

Key topics and requirements

• Defined terminology and units for optical measurements relevant to IOLs (power, focal length, vergence, etc.).
• Standardized methods to measure dioptric power and focal length under specified conditions.
• Procedures and acceptance criteria for assessing image quality metrics (e.g., modulation transfer function, point spread behavior, wavefront aberration descriptors).
• Test methods for toric IOLs including axis orientation, cylinder power and rotational alignment verification.
• Requirements for measuring optical surface and lens geometry that affect optical performance (surface form, centration, optical zone).
• Guidance on measurement equipment and environmental/test conditions (illumination, pupil size equivalents, measurement apertures).
• Required reporting elements and presentation of test data to support regulatory submissions and comparability between devices.
• Notes on applicability to different optical designs (monofocal, simultaneous-vision, accommodative) and inclusion of phakic IOLs where relevant.

Typical use and users

Manufacturers of intraocular lenses use ISO 11979-2:2024 for design verification, routine quality control and to generate standardized optical data for technical files and regulatory submissions. Notified bodies, conformity assessment laboratories and test houses apply the standard when evaluating optical performance. Research groups and clinicians involved in device performance assessment or comparative studies may also rely on the described measurement methods to produce comparable optical data.

Related standards

ISO 11979-2:2024 is one part of the ISO 11979 series for intraocular lenses. Closely related parts and documents include ISO 11979-1 (vocabulary/general requirements), ISO 11979-3 (mechanical properties and test methods), ISO 11979-4 (labelling and information), ISO 11979-5 (biocompatibility), ISO 11979-6 (shelf-life and transport stability), ISO 11979-7 (clinical investigations) and ISO 11979-9 / -10 (multifocal and phakic IOLs). It is commonly used together with general medical device standards and test standards such as the ISO 10993 series (biocompatibility) and ISO 11607 (packaging for terminally sterilized medical devices) when preparing comprehensive device documentation.

Keywords

intraocular lens; IOL; optical properties; optical test methods; optical power; focal length; modulation transfer function; wavefront aberration; toric IOL; phakic IOL; monofocal; simultaneous vision; accommodative lens; ISO 11979

FAQ

Q: What is this standard?

A: ISO 11979-2:2024 is an international standard that specifies optical properties and laboratory test methods for intraocular lenses. It defines how key optical measurements should be performed and reported so results are comparable between devices and testing laboratories.

Q: What does it cover?

A: It covers definitions, measurement conditions and standardized methods for evaluating optical power, focal performance, imaging quality metrics (e.g., MTF/wavefront descriptors), and toric lens alignment. The document applies to monofocal, toric, simultaneous-vision and accommodative IOLs and includes provisions applicable to phakic IOLs.

Q: Who typically uses it?

A: Primary users are IOL manufacturers, product development and quality-control laboratories, regulatory and conformity assessment bodies, and test laboratories that perform optical evaluations of IOLs. Clinical researchers and consultants may also use it when comparing optical performance across devices.

Q: Is it current or superseded?

A: ISO 11979-2:2024 is the current edition (Edition 3, published in October 2024). It supersedes the previous edition ISO 11979-2:2014.

Q: Is it part of a series?

A: Yes — it is Part 2 of the ISO 11979 series, which covers intraocular lenses. The series includes multiple parts addressing vocabulary, mechanical testing, biocompatibility, labelling, shelf-life, clinical investigations and specific lens types (for example, multifocal and phakic IOLs).

Q: What are the key keywords?

A: Key keywords include intraocular lens, IOL, optical properties, optical test methods, optical power, focal length, modulation transfer function, wavefront, toric, phakic, monofocal, simultaneous vision, accommodative.