ANSI Z80.30-2018 pdf free download – Ophthalmics – Toric Intraocular Lenses
5Optical requirements5.1Scope
This clause applies to the optical properties and performance requirements of the toric IOL in its finalform, as intended for implantation in the human eye.
5.2Requirements
5.2.1 Dioptric power
Dioptric power is defined in ISO 11979-1. When determined by one of the methods described in Annex Aof lISo 1i979-2, the dioptric power in the meridians of highest and lowest dioptric power and the
spherical equivalent power shall be within the tolerance limits for dioptric power specified in ISO 11979-2.Additionally, the cylinder calculated by the absolute difference between the powers of the meridian ofthe highest dioptric power and the meridian of the lowest dioptric power shall be within the cylindricalpower tolerance limits specified in ISO 11979-2.
5.2.2Axis orientation mark(s)
The toric IOL shall have some physical mark, engraving or label to indicate the cylindrical axis. The
angle difference between the physical axis indicator and the meridian with the lowest dioptric power shallbe less than or equal to 5.08.
5.2.3Imaging quality
When the null lens method outlined in Annex A is used, the resolution efficiency requirements in ISO11979-2 shall apply to the combined system of toric IOL and null lens. Alternatively, the ModulationTransfer Function (MTF) requirements of ISO 11979-2 shall apply to the meridians of highest and lowestdioptric power of the combined system of toric IOL and null lens.
When other metrics or methods are used to assess toric lOL image quality, the manufacturer shall verifythat toric IOLs that meet the minimum requirement of the new metric also meet either the resolutionefficiency or MTF requirements of ISo 1i979-2.The method in Annex A may be useful for suchverification tests. An example of an alternative image quality metric and method is provided inAnnex C.
5.2.4Spectral transmittance
The requirements in ANSI Z80.7 shall apply.
NOTE: Additional information may be found in ISO 18369-3 and lSO 11979-2.6Mechanical requirements
6.1 Scope
This clause applies to the mechanical properties and performance requirements of toric IOLs in theassembled or final form, as intended for implantation in the human eye.
6.2Requirements
For the purpose of establishing the following requirements, toric IOLs with the lowest and highest labeledcylindrical power and the lowest and highest spherical powers that will be manufactured shall be used.
6.2.1 Toric IOLs for the correction of aphakia
The requirements in ISO 11979-3 shall apply.
6.2.2 Toric IOLs for the modification of the refractive power of the phakic eye
The requirements of ANSIZ80.13 shall apply, noting that ANSI Z80.13 references ISO 11979-3:1999specifically.
Biocompatibility requirements
7.1Scope
This section applies to the biocompatibility requirements for the toric lOL in the assembled or final form,as intended for implantation in the human eye.”
7.2General guidelines
Animals shall be cared for in accordance with lSO 10993-2.
Unless otherwise indicated, the materials used in biological testing can either be the sterile finished toricIOLs or facsimile materials fabricated and processed in a manner equivalent to that used for the toricIOLs. The manufacturer shall establish and document equivalency in material and in test sensitivity,where appropriate, for the test sample and the sterile finished toric IOL.
7.3Biological 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 thepotential for material changes such as calcification following implantation.The risk analysis shouldconsider 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 monocular implantation test to assess the stability of the materialshall be performed as outlined in ISO 11979-5.ANSI Z80.30 pdf download.