| ISO 11979-3 Third edition 2012-12-01 Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods |
| Recognition Date | 2013-08-06 |
| Recognition List | 031 |
| Recognition Number | 10-78 |
| 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 requirements and test methods for certain mechanical properties of intraocular lenses (IOLs).
It is applicable to all types of IOLs intended for implantation in the anterior segment of the human eye, excluding corneal implants, provided that the test method is appropriate to the particular IOL design.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.4300 | Folders And Injectors, Intraocular Lens (Iol) | Class 1 | MSS |
| §886.4300 | Injector, Capsular Tension Ring | Class 1 | NCE |
| §886.4300 | Lens, Guide, Intraocular | Class 1 | KYB |
| §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. |