| ANSI Z80.20-2016 American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties |
| Recognition Date | 2017-08-21 |
| Recognition List | 047 |
| Recognition Number | 10-104 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Subclause 5.1, paragraph 2 - Deviations from manufacturing tolerances |
| Standards Orgs | ANSI American National Standards Institute https://www.ansi.org/ |
| STG | Ophthalmic |
| FDA Tech | J. Angelo Green FDA/OMPT/CDRH/ODE/DOED/CLRD/ 301-796-6860 angelo.green@fda.hhs.gov |
This standard is recognized on a scientific basis: performance specification. NOTE: Although the standard states the tolerances might not apply beyond the time of manufacture, manufacturers may use this standard for the purposes of finished product specifications and shelf-life studies.
Applies to contact lenses worn over the front surface of the eye in contact with the preocular tear film. The standard covers rigid intracorneal and haptic (scleral) contact lenses, as well as soft paralimbal contact lenses.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.5925 | Lens, Contact, (Disposable) | Class 2 | MVN |
| §886.5925 | Lenses, Soft Contact, Daily Wear | Class 2 | LPL |
| §886.5925 | Lenses, Soft Contact, Extended Wear | Class 3 | LPM |
| 1. Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, Issued May 1994. 2. ISO 18369-1 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications. 3. ISO 18369-2 Ophthalmic optics - Contact lenses - Part 2: Tolerances. 4. ISO 18369-3 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods. 5. ISO 18369-4 Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials. |