Recognized standard
Z80.18-2016 (R2021)
FDA recognition 10-103 · ANSI · Ophthalmic
Key facts
| Recognition number | 10-103 |
|---|---|
| Designation | Z80.18-2016 (R2021) |
| Title | American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology |
| Standards developer | American National Standards Institute |
| Specialty area | Ophthalmic |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2 |
| Scope (excerpt) | This American National Standard applies to contact lens care products (CLCP) which are marketed for use with hard (PMMA), rigid gas permeable (RGP), enhanced oxygen permeable materials, and soft hydrophilic contact lenses. |
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: