Recognized standard
11979-2 Second edition 2014-08-15
FDA recognition 10-98 · ISO · Ophthalmic
Key facts
| Recognition number | 10-98 |
|---|---|
| Designation | 11979-2 Second edition 2014-08-15 |
| Title | Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 3 |
| Scope (excerpt) | This part of ISO 11979 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or accommodative optics. The generic descriptor 'IOL' used throughout this document also includes phakic… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
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About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: