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ANSI Z80.12
Ophthalmics – Multifocal Intraocular Lenses
Organization:
ANSI - American National Standards Institute
Year: 2007
Abstract: Scope and purpose
This standard applies to any ocular implant whose primary indication is the correction of aphakia and whose optic is designed to provide simultaneous distance and near vision. For the purposes of this standard, these implants are referred to as multifocal intraocular lenses (MIOLs). This standard does not consider optics designed to provide astigmatic power correction. The term "near vision", as used in this standard, includes useful vision at the distance of claimed benefit; e.g., near and/or intermediate distances.
This standard addresses specific requirements for MIOLs that are not addressed in the normative references, and includes 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 whose optic is designed to provide simultaneous distance and near vision. For the purposes of this standard, these implants are referred to as multifocal intraocular lenses (MIOLs). This standard does not consider optics designed to provide astigmatic power correction. The term "near vision", as used in this standard, includes useful vision at the distance of claimed benefit; e.g., near and/or intermediate distances.
This standard addresses specific requirements for MIOLs that are not addressed in the normative references, and includes 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.
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| contributor author | ANSI - American National Standards Institute | |
| date accessioned | 2017-09-04T15:38:57Z | |
| date available | 2017-09-04T15:38:57Z | |
| date copyright | 2007.03.26 | |
| date issued | 2007 | |
| identifier other | AZPYVEAAAAAAAAAA.pdf | |
| identifier uri | https://yse.yabesh.ir/std/handle/yse/41090 | |
| description abstract | Scope and purpose This standard applies to any ocular implant whose primary indication is the correction of aphakia and whose optic is designed to provide simultaneous distance and near vision. For the purposes of this standard, these implants are referred to as multifocal intraocular lenses (MIOLs). This standard does not consider optics designed to provide astigmatic power correction. The term "near vision", as used in this standard, includes useful vision at the distance of claimed benefit; e.g., near and/or intermediate distances. This standard addresses specific requirements for MIOLs that are not addressed in the normative references, and includes 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. | |
| language | English | |
| title | ANSI Z80.12 | num |
| title | Ophthalmics – Multifocal Intraocular Lenses | en |
| type | standard | |
| page | 42 | |
| status | Active | |
| tree | ANSI - American National Standards Institute:;2007 | |
| contenttype | fulltext |