ISO 11979-6 Third edition 2014-10-01 Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing |
Recognition Date | 2015-08-14 |
Recognition List | 040 |
Recognition Number | 10-95 |
Extent | Complete standard |
Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
STG | Ophthalmic |
FDA Tech | Claudine Krawczyk FDA/OMPT/CDRH/ODE/DOED/ICIB/ 301-796-6860 claudine.krawczyk@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
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 |
There is no relevant guidance developed at this time. |