Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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040
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Date of Entry 08/14/2015
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FR Recognition Number
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10-95
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Standard | |
ISO 11979-6 Third edition 2014-10-01 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing |
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Scope/AbstractThis 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. |
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Extent of Recognition
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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. |
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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 |
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Unclassified |
Lens, Intraocular, Phakic |
Class 3 |
MTA |
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |