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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 018 Date of Entry 09/12/2007 
FR Recognition Number 10-48
Standard
ISO 11979-5 Second edition 2006-06-01
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility egg
Scope/Abstract
This part of ISO 11979 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.
Transition Period
FDA recognition of ISO 11979-5 Second edition 2006-06-01 [Rec# 10-48] will be superseded by recognition of ISO 11979-5 Third edition 2020-09 [Rec# 10-119]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 10-48] until December 19, 2021. After this transition period, declarations of conformity to [Rec# 10-48] 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, 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
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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