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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 10-108
Standard
ISO  18369-2 Third edition 2017-08
Ophthalmic optics - Contact lenses - Part 2: Tolerances
Scope/Abstract
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.
Extent of Recognition
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.
Rationale for Recognition
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.
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. 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
 J. Angelo Green
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6860
  angelo.green@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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