| ISO 18369-3 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 3: Measurement Methods |
| Recognition Number | Ophthalmic |
| Recognition Date | 2018-06-07 |
| Recognition List | 049 |
| Recognition Number | 10-106 |
| 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 specifies the methods for measuring the physical and optical properties of contact lenses specified in ISO 18369-2, i.e. radius of curvature, label back vertex power, diameter, thickness, inspection of edges, inclusions and surface imperfections and determination of spectral transmittance. This document also specifies the equilibrating solution, i.e. standard saline solution, for testing 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. ANSI Z80.20 American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties. |