ANSI Z80.12-2007 (R2017)
2007
Ophthalmics – Multifocal Intraocular Lenses
- Format:
- Language(s) :
- Published :
- English
- 2007
ANSI Z80.12-2007 (R2017) 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.
ANSI Z80.12-2007 (R2017) | |
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STANDARD INFO: | |
Standard Name | ANSI Z80.12-2007 (R2017) |
Scope | Ophthalmics - Multifocal Intraocular Lenses |
Publisher | ANSI - American National Standards Institute |
Languages | English |
State | |
Publication Year | 2007 |
Most recent Version | MOST RECENT |
Whether to be replaced | |
Addendum | |
FILE INFO: | |
File Size | 1 file , 410 KB |
Note | This product is unavailable in Ukraine, Russia, Belarus |
Number of Pages | 42 |
Published | 2007 |
ANSI Z80.12-2007 (R2017) | ||
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History | Publisher Year | |
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