| ISO 11979-5 Second edition 2006-06-01 Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility |
| Recognition Date | 2007-09-12 |
| Recognition List | 018 |
| Recognition Number | 10-48 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Ophthalmic |
| FDA Tech | Simona Bancos FDA/OMPT/CDRH/ODE/DOED/ICIB/ 301-796-6860 simona.bancos@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 particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.
| 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. |