| ISO 18369-2 Third edition 2017-08 Ophthalmic optics - Contact lenses - Part 2: Tolerances |
| Recognition Number | Ophthalmic |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 10-108 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized Section 6 Tolerances for soft contact lenses, Paragraphs 3, 4 and 5. |
| 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 recognized on a scientific basis: performance specification. NOTE: Although the scope of 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. This standard is recognized in part because: Section 6, Paragraphs 3, 4 and 5, do not satisfy a premarket requirement under the FD&C Act for these devices.
This document specifies the tolerance limits of the principal optical and physical parameters of rigid corneal, rigid scleral and soft contact lenses at the time of manufacture.
These tolerances might not apply to other purposes, for example, shelf-life studies.
| 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. |