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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 10-119
Standard
ISO 11979-5 Third edition 2020-09
Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
Scope/Abstract
This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.
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
Unclassified Lens, Intraocular, Phakic Class 3 MTA
§886.3600 Extended Depth Of Focus Intraocular Lens Class 3 POE
§886.3600 Intraocular Lens Class 3 HQL
§886.3600 Lens, Intraocular, Accommodative Class 3 NAA
§886.3600 Lens, Intraocular, Toric Optics Class 3 MJP
§886.3600 Lens, Iris Reconstruction Class 3 NIZ
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
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
 Simona Bancos
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6860
  simona.bancos@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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