Recognized standard
18369-2 Third edition 2017-08
FDA recognition 10-108 · ISO · Ophthalmic
Key facts
| Recognition number | 10-108 |
|---|---|
| Designation | 18369-2 Third edition 2017-08 |
| Title | Ophthalmic optics - Contact lenses - Part 2: Tolerances |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This document specifies the tolerance limits of the principal optical and physical parameters of rigid corneal, rigid scleral and soft contact lenses at the time of manufacture. These tolerances might not apply to other purposes, for example, shelf-life studies. |
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: