Recognized standard
11978 Third edition 2017-08 [Including AMD1:2020]
FDA recognition 10-141 · ISO · Ophthalmic
Key facts
| Recognition number | 10-141 |
|---|---|
| Designation | 11978 Third edition 2017-08 [Including AMD1:2020] |
| Title | Ophthalmic optics - Contact lenses and contact lens care products - Labelling [Including Amendment 1 (2020)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Ophthalmic |
| Date of entry | Dec 22, 2025 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | ISO 11978:2017 specifies the information to be provided by the manufacturer of contact lenses and contact lens care products to ensure the correct and safe use of these devices and their accessories by both types of user of contact lenses: the eye care professional and the contact lens wearer. |
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: