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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 045 Date of Entry 09/21/2016 
FR Recognition Number 10-101
Standard
ISO  18189 First edition 2016-06-01
Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
Scope/Abstract
This International Standard describes an in vitro test method to assess the potential cytotoxic effects that may arise due to interaction of contact lenses with contact lens care solutions.
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
§886.5925 Lenses, Soft Contact, Daily Wear Class 2 LPL
§886.5925 Lenses, Soft Contact, Extended Wear Class 3 LPM
§886.5925 Lens, Contact, For Color Vision Deficiency Class 2 NCZ
§886.5925 Lens, Contact, For Reading Discomfort Class 2 NIC
21 CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies
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
 Chandramallika (Molly) Ghosh
  FDA/OC/CDRH/OPEQ/OHTV/DHTVB/
  301-796-6496
  molly.ghosh@fda.hhs.gov
 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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