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ISO 11979-2-2014 pdf free download
ISO 11979-2-2014 pdf free download.Ophthalmic implants Intraocular lenses Part 2:Optical properties and test methods
Implants ophtalmiques — Lentilles intraoculaires — Partie 2: Pro priétés optiques et méthodes d’essai.
In order to best control the MTF 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 oft 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 IOL 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.
4.3.5 Accommodating IOL (AIOL)
The requirements given in 4I2 shall apply at the far power configuration and configurations associated with the designed range of accommodation. Measurements shall be obtained in 0,5 D or smaller increments over this range if applicable.
4.3.6 Combination of optical principles
For toric niultilocal and toric accommodating lenses, the general imaging requirements for all principles in 4,33 apply along with the special test requirements In 43A and 4.3.5. respectively.
For multifocal accommodating lenses the imaging requirements of 4.14 and 43.5 apply.
If the criteria specified in 43.2 through 4.3.6. for reasons of theoretical limitation, cannot be applied to negative and low power lenses in conjunction with the model eye described, the manufacturer shall justify any alternate spatial frequencies and criteria applied.
4.4 Spectral transmittance
4.4.1 Measurement of spectral transmittance
The spectral transmittance in the range 300 nm to 1 100 nm shall be recorded by a UV/Visible spectrophotometer with a 3 mm aperture in aqueous, or he corrected for specular reflection if measured in air. The measurement should be accurate to ± 2 % transmittance and the resolution should not be less than 5 nm. The test specimen shall be either an actual IOL or a flat facsimile of the 101 optic material, having a thickness equal to the centre thickness of a 20 D lOL and having undergone the same production treatment as the finished 101 including sterilization.
4.4.2 Cut-off wavelength
Designate UV cut-off as UV(XXX) where XXX is the wavelength in nanometres at which the spectral transmission is below 10 % when measured according to 4il.ISO 11979-2-2014 pdf free download.
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