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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 10-98
Standard
ISO  11979-2 Second edition 2014-08-15
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
Scope/Abstract
This part of ISO 11979 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or accommodative optics. The generic descriptor 'IOL' used throughout this document also includes phakic intraocular lenses (PIOL).
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.
Transition Period
FDA recognition of ISO 11979-2 Second edition 2014-08 [Rec# 10-98] will be superseded by recognition of ISO 11979-2 Third edition 2024-10 [Rec# 10-137]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-98] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 10-98] will not be accepted.
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 Contacts
 Simona Bancos
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-2243
  simona.bancos@fda.hhs.gov
 Bennett Walker
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-5093
  Bennett.Walker@fda.hhs.gov
 Janet Tang
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  --
  Janet.Tang@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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