ANSI Z80.30-2010 pdf download Ophthalmics – Toric Intraocular Lenses
7.3 Biological test requirements
The requirements in 7.3 of ANSI Z80.7 shall apply, with the following additional requirements:
Manufacturers of new toric IOL materials shall include in their risk analysis an assessment of the potential for material changes such as calcification following implantation. The risk analysis should consider the history of clinical use of the material, and tests to assess the long-term stability of the material in an in-vivo environment. A nonocular implantation test to assess the stability of the material shall be performed as outlined in ISO 11979-5.
After the light microscopy evaluation of the explanted toric IOLs from the ocular implantation test (ANSI Z80.7, Annex C), half of the samples shall be thoroughly cleaned (if the optical surfaces can be cleaned without being damaged) and then assessed for changes in optical properties in accordance with the requirements in clause 5 of this standard. The other half of the samples shall then be evaluated by SEM/ EDX, where feasible, for surface changes.
NOTE: The test or control material used for the ocular implantation test (ANSI Z80.7, Annex C) may be a representative sample of the toric IOL that has gone through the same fabrication methods as the device to be marketed, has a mass at least equivalent to the finished toric IOL, and has a size and shape that would allow the required post-retrieval evaluations to be performed, if its use can be justified.
7.4 Physicochemical test requirements The requirements in 7.4 of ANSI Z80.7 shall apply, with the following additional requirements: The dioptric power shall be determined before and after testing if finished toric IOLs are used in hydrolysis testing. The refractive index shall be determined instead if a facsimile material is used. The dioptric power shall be within the tolerance limits in Table 1 in 5.2.1 before and after hydrolysis testing, or the refractive index change should be used to determine the resulting power change for the nominal design and this difference shall be within the tolerance limits in Table 1 in 5.2.1.
ANSI Z80.30-2010 pdf download
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