| ISO 18369-1 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications |
| Recognition Number | Ophthalmic |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 10-109 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.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 relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This document identifies and defines the terms applicable to the physical, chemical and optical properties of contact lenses, their manufacture and uses. It provides a vocabulary of terms and, when appropriate, the international symbol and abbreviation associated with a specific term. This document also defines the terms relating to contact lens care products. It also incorporates the classifications of contact lens materials and gives recommendations for the labelling of the specifications of contact lenses.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.5925 | Lens, Contact, (Disposable) | Class 2 | MVN |
| §886.5925 | Lens, Contact, For Color Vision Deficiency | Class 2 | NCZ |
| §886.5925 | Lens, Contact, For Reading Discomfort | Class 2 | NIC |
| §886.5925 | Lenses, Soft Contact, Daily Wear | Class 2 | LPL |
| §886.5925 | Lenses, Soft Contact, Extended Wear | Class 3 | LPM |
| §886.5925 | System, In-Office Tinting, Contact Lenses | Class 2 | MZD |
| §886.5916 | Lens, Contact (Orthokeratology) | Class 2 | MUW |
| §886.5916 | Lens, Contact (Other Material) - Daily | Class 2 | HQD |
| §886.5916 | Lens, Contact (Rigid Gas Permeable), Extended Wear | Class 3 | MWL |
| §886.5916 | Lens, Contact, Orthokeratology, Overnight | Class 3 | NUU |
| 1. Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, Issued May 1994. 2. Hutter, J.C., Green, J.A., & Eydelman, M.B. (2012). Proposed Silicone Hydrogel Contact Lens Grouping System for Lens Care Product Compatibility Testing. Eye and Contact Lens, 38(6), 358-362. 3. ANSI Z80.20 American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties. |