The EN ISO 11979 standard, which is a European standard and also published by the International Standards Organization (ISO), consists of the following sections under the main heading of "Ophthalmic implants - Intraocular lenses":
The EN ISO 11979-1 standard defines terms applicable to intraocular lenses and the methods used to evaluate them. For the purposes of this standard, suitable intraocular lens refers to an intraocular lens that allows continuous focusing from the far point to the near point by varying the dioptric power of the eye. Accommodative amplitude expresses the difference in refractive power between the near point and the far point of the eye. The additive power refers to the difference between the distance power and the near power of the lens part, measured under certain conditions. An accelerated shelf life study refers to a stability study designed to increase the rate of chemical or physical degradation of a product by using exaggerated storage conditions, such as temperature and humidity, to determine the temporary expiration date and kinetic degradation parameters.
The EN ISO 11979-2 standard describes requirements and test methods for certain optical properties of intraocular lenses with any of the spherical, aspherical, monofocal, toric, multifocal or compatible optics. The manufacturer must demonstrate that all available powers meet the specifications herein. All optical properties are applied to in situ conditions, either by measuring in simulated in situ conditions or by measuring in other conditions and then correcting for in situ conditions.
EN ISO 11979-3 standard describes the requirements and test methods for specific mechanical properties of intraocular lenses. The test method applies to all types of intraocular lenses intended for implantation into the anterior segment of the human eye, excluding corneal implants, provided the method is suitable for the design of the specific intraocular lens. Mechanical properties for all intraocular lenses shall be determined in situ. The exact composition of the solution used must be reported in each case. If a justification for deviation from the in-situ test is given, alternative test conditions, e.g., room temperature conditions, may be used. Alternative test conditions must be stated in the test reports.
The EN ISO 11979-4 standard describes the labeling requirements for intraocular lenses and the information to be provided on or on the packaging.
The EN ISO 11979-5 standard describes specific requirements for the assessment of biocompatibility of intraocular lens materials, including the processing conditions for their manufacture. These requirements include evaluation of physicochemical properties related to biocompatibility. It also provides guidance on performing an ocular implantation test. Evaluation of the biocompatibility of the test material begins with an initial risk assessment according to the ISO 14971 standard. As a minimum, the tests described in this standard should be performed to characterize the physicochemical properties of the intraocular lens, regardless of the result of the initial risk assessment. Evaluation of the material in terms of biological safety is made according to the biological evaluation plan, taking into account the results of the physicochemical tests and in accordance with the principles and requirements explained in the first and second sections.
The EN ISO 11979-6 standard describes test methods by which the shelf life of sterile intraocular lenses in their final packaging can be determined. These tests include procedures to ensure the stability of intraocular lenses in distribution and storage. If, following a risk analysis according to the ISO 14971 standard, a product stability study, a package integrity study or a transport stability study is needed, the ISO 11979-6 standard will apply to the planning and execution of these studies.
The EN ISO 11979-7 standard describes specific requirements for clinical investigations of intraocular lenses implanted in the eye to correct aphakia. First, a risk analysis is applied according to the ISO 14971 standard. If the risk analysis identifies a clinical research need, the requirements described in the ISO 11979 standard will be applied, along with the additional requirements given in the EN ISO 7-14155 standard.
The standard EN ISO 11979-8 describes the basic requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, with the exception of corneal implants and transplants.
The EN ISO 11979-9 standard applies to any intraocular lens whose optics provide two or more rotationally symmetric powers and whose primary indication is the correction of aphakia with the added benefit of useful vision at multiple distances (e.g., near and far). As used in this standard, the term near vision includes useful vision at distances in the claimed benefit, such as near or intermediate distances. This standard is applicable to the physical characteristics of multifocal intraocular lenses, mounted or in their final form, intended for implantation in the human eye. For tolerances and dimensions, the requirements of the ISO 11979-3 standard apply, with the additional requirement that the manufacturer must specify tolerances relating to the optical design.
The standard EN ISO 11979-10 describes the requirements for any intraocular lens to be implanted in the anterior segment of the eye to change the refractive power of the primary indication. Depending on the optical design, there are three main categories of phakic intraocular lenses: phakic monofocal, phakic multifocal, and phakic toric. Each of these categories is also designed for implantation in the anterior or posterior chamber of the anterior segment of the eye. Basic phakic optical eye lens requirements apply to all types.
Optical requirements must comply with the requirements described in part two, mechanical requirements in part three, biocompatibility requirements in part five, shelf life and transport stability requirements in part six, and basic requirements in part eight.
Our organization also provides testing services for intraocular lenses, which are ophthalmic implants, within the scope of EN ISO 11979 standard, with its trained and expert staff and advanced technological equipment, among the numerous test, measurement, analysis and evaluation studies it provides for businesses in various sectors.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
