Recognized standard
18369-4 Second edition 2017-08
FDA recognition 10-107 · ISO · Ophthalmic
Key facts
| Recognition number | 10-107 |
|---|---|
| Designation | 18369-4 Second edition 2017-08 |
| Title | Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Jun 7, 2018 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This document specifies the methods of testing the physicochemical properties of contact lens materials. These are extraction, rigid lens flexure and breakage, oxygen permeability, refractive index and water content. |
At a glance
- 10–99 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: