Recognized standard
11979-5 Third edition 2020-09
FDA recognition 10-119 · ISO · Ophthalmic
Key facts
| Recognition number | 10-119 |
|---|---|
| Designation | 11979-5 Third edition 2020-09 |
| Title | Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 3 |
| Scope (excerpt) | This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives… |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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: