| 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
|
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
|
| §886.3600 |
Extended Depth Of Focus Intraocular Lens
|
Class 3
|
POE
|
| 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
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
