Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
049
|
Date of Entry 06/07/2018
|
FR Recognition Number
|
10-109
|
Standard | |
ISO 18369-1 Second edition 2017-08 Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications |
|
Scope/AbstractThis 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. |
|
Extent of Recognition
|
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
|
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§886.5916 |
Lens, Contact (Other Material) - Daily
|
Class 2
|
HQD
|
§886.5916 |
Lens, Contact (Orthokeratology)
|
Class 2
|
MUW
|
§886.5916 |
Lens, Contact (Rigid Gas Permeable), Extended Wear
|
Class 3
|
MWL
|
§886.5916 |
Lens, Contact, Orthokeratology, Overnight
|
Class 3
|
NUU
|
§886.5925 |
Lenses, Soft Contact, Daily Wear
|
Class 2
|
LPL
|
§886.5925 |
Lenses, Soft Contact, Extended Wear
|
Class 3
|
LPM
|
§886.5925 |
Lens, Contact, (Disposable)
|
Class 2
|
MVN
|
§886.5925 |
System, In-Office Tinting, Contact Lenses
|
Class 2
|
MZD
|
§886.5925 |
Lens, Contact, For Color Vision Deficiency
|
Class 2
|
NCZ
|
§886.5925 |
Lens, Contact, For Reading Discomfort
|
Class 2
|
NIC
|
|
Relevant FDA Guidance and/or Supportive Publications*
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.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
|
FDA Technical Contact
|
Standards Development Organization
|
FDA Specialty Task Group (STG)
|
*These are provided as examples and others may be applicable. |
|
|