Recognized standard
11979-3 Third edition 2012-12-01
FDA recognition 10-78 · ISO · Ophthalmic
Key facts
| Recognition number | 10-78 |
|---|---|
| Designation | 11979-3 Third edition 2012-12-01 |
| Title | Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 3, Class 1 |
| Scope (excerpt) | This part of ISO 11979 specifies requirements and test methods for certain mechanical properties of intraocular lenses (IOLs). It is applicable to all types of IOLs intended for implantation in the anterior segment of the human eye, excluding corneal implants, provided that the test method is… |
At a glance
- 1–9 Product codes
- None 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: