Recognized standard
18369-3 Second edition 2017-08
FDA recognition 10-106 · ISO · Ophthalmic
Key facts
| Recognition number | 10-106 |
|---|---|
| Designation | 18369-3 Second edition 2017-08 |
| Title | Ophthalmic optics - Contact lenses - Part 3: Measurement Methods |
| 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 for measuring the physical and optical properties of contact lenses specified in ISO 18369-2, i.e. radius of curvature, label back vertex power, diameter, thickness, inspection of edges, inclusions and surface imperfections and determination of spectral… |
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: