ISO 11979-2:2014 pdf free

ISO 11979-2:2014 pdf free.Ophthalmic implants一Intraocular lenses一Optical properties and test methods
The power associated with the far power configuration of an AIOL shall be determined by one of the methods in Annex A. When determined by one of these methods, the dioptric power tolerances specified in Table 1 shall apply to the power associated with the far power configuration of the AIOL. The dioptric change of the lens or system in the eye resulting from the accommodative action shall be determined in a theoretical or laboratory eye model.
Imaging quality is dependent upon compatibility between the optical design and conditions that are used to evaluate optical performance. Imaging quality can be specified either as resolution efficiency or as the modulation transfer function (MTF) value at a specified spatial frequency. Resolution efficiency is determined according to the method described in Annex B. MTF is measured according to the method in Annex C.
MTF determined with the method described in Annex C is dependent on the compatibility between the optical design and model eye that is used to evaluate optical performance. For the method described in Annex C, example model eye specifications are given. Alternatively, the manufacturer can specify an equivalent method or model eye with optical properties for the intended use and design. In this case the model eye and the method shall be fully described and a justification for the use be provided. The imaging quality specifications apply to all available powers, unless stated otherwise.
In order to best control the MTP performance of the MIOL, the small and large apertures used for testing shall be chosen and defined for the lens model over the range of apertures provided above with a tolerance of±0,1 mm. The manufacturer shall have the option of setting the minimum MTF specification based on the area under the curve between the two spatial frequencies or on the MTF value for each individual spatial frequency. The MTF shall be greater than or equal to 70 % of the maximum theoretically attainable modulation for the specific I0L design. Alternatively, the minimum MTF specification shall be set such that it results in an acceptable visual outcome, verifiable, or to be verified, by clinical data.ISO 11979-2 pdf download.