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ANSI Z80.29
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ANSI Z80.29 2015 Edition, May 28, 2015 Ophthalmics – Accommodative Intraocular Lenses
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Description / Abstract:
Scope and purpose
This standard applies to any ocular implant whose primary indication is the correction of aphakia and is designed to provide vision over a continuous range of distances by affecting a change in the vergence power of the eye resulting from the implant design that changes eye optical power or implant position in response to a stimulus. For the purposes of this standard, these implants are referred to as accommodative intraocular lenses (AIOLs).
This standard addresses specific requirements for AIOLs that are not addressed in the normative references, and include vocabulary, optical properties and test methods, mechanical properties and test methods, labeling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device. As with any standard, alternative validated test methods may be used.
This standard applies to any ocular implant whose primary indication is the correction of aphakia and is designed to provide vision over a continuous range of distances by affecting a change in the vergence power of the eye resulting from the implant design that changes eye optical power or implant position in response to a stimulus. For the purposes of this standard, these implants are referred to as accommodative intraocular lenses (AIOLs).
This standard addresses specific requirements for AIOLs that are not addressed in the normative references, and include vocabulary, optical properties and test methods, mechanical properties and test methods, labeling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device. As with any standard, alternative validated test methods may be used.