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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 040 Date of Entry 08/14/2015 
FR Recognition Number 10-97
Standard
ISO  13212 Third edition 2014-09-01
Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
Scope/Abstract
This International Standard provides guidance on the design of stability studies for use in gathering information to enable determination of the shelf-life of contact lens care products.

This International Standard does not address studies designed to obtain information to establish the in-use stability (i.e. notice of discard date) of contact lens care products.
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
§886.5918 Rigid gas permeable contact lens care products.
§886.5928 Soft (hydrophilic) contact lens care products.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Issued May 1, 1997

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
 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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