| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
040
|
Date of Recognition 08/14/2015
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FR Recognition Number
|
10-95
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StandardISO 11979-6 Third edition 2014-10-01
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing |
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Scope/Abstract| This 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. |
|
| 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. |
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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 |
|
| Unclassified |
Lens, Intraocular, Phakic |
Class 3 |
MTA |
|
Relevant FDA Guidance and/or Supportive Publications
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact
|
| Standards Development Organization
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| FDA Specialty Task Group (STG)
|
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