| ISO 11979-1 Third edition 2012-09-15 Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 10-79 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Ophthalmic |
| FDA Tech | Don Calogero FDA/OMPT/CDRH/ODE/DOED/ICIB/ 301-796-6483 don.calogero@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 defines terms applicable to intraocular lenses and to the methods used to evaluate them.
| 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 |
| There is no relevant guidance developed at this time. |