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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 041 Date of Entry 04/04/2016 
FR Recognition Number 10-100
Standard
ISO  18259 First Edition 2014-10-01
Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
Scope/Abstract
This International Standard specifies an antimicrobial efficacy end point methodology to determine compatibility of contact lens solutions, lens cases and hydrogel lenses for disinfection. This provides a process for evaluating compatibility of solutions used for disinfection with contact lenses and lens cases using an antimicrobial efficacy end point. Specifically, the microbiological effect of the antimicrobial agent(s) while in the presence of the lens cases and/or lenses will be evaluated as described in the soak step of the label instructions.

For practical purposes, this does not apply to oxidative systems.
Extent of Recognition
Complete standard
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
§886.5918 Products, Contact Lens Care, Rigid Gas Permeable Class 2 MRC
§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 Lens, Contact, For Color Vision Deficiency Class 2 NCZ
§886.5925 Lens, Contact, For Reading Discomfort Class 2 NIC
§886.5928 Accessories, Soft Lens Products Class 2 LPN
Relevant FDA Guidance and/or Supportive Publications*
Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, Issued May 1994
http://www.fda.gov/RegulatoryInformation/Guidances/ucm080928.htm

Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Issued May 1, 1997
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080218.pdf


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 Contacts
 Jeffrey Brocious
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/BAC2/
  240-402-3797
  jeffrey.brocious@fda.hhs.gov
 Scott Steffen
  FDA/OC/CDRH/OSPTI/DAHRSSP/
  240-402-8795
  scott.steffen@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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