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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 10-95
Standard
ISO  11979-6 Third edition 2014-10-01
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
Scope/Abstract
This part of ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.
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
§886.3600 Intraocular Lens Class 3 HQL
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
§886.3600 Lens, Intraocular, Toric Optics Class 3 MJP
§886.3600 Lens, Intraocular, Accommodative Class 3 NAA
§886.3600 Lens, Iris Reconstruction Class 3 NIZ
N/A Lens, Intraocular, Phakic Class 3 MTA
Relevant FDA Guidance and/or Supportive Publications*
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
 Claudine Krawczyk
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6860
  claudine.krawczyk@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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