| ISO TR 22979 First edition 2006-02-01 Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications |
| Recognition Date | 2011-03-18 |
| Recognition List | 026 |
| Recognition Number | 10-63 |
| 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.
ISO/TR 22979:2006 provides guidance on the application of Parts 3, 7 and 9 of the ISO 11979 series of International Standards for intraocular lenses (IOLs). It addresses factors to be considered in a risk analysis of the significance of modifications to anterior and posterior chamber, monofocal and multifocal, intraocular lenses. It also suggests methods of data analysis and interpretation that can be used to determine the need for and the design of a clinical investigation.
| Regulation Number | Device Name | Device Class | Product Code |
| §886.3600 | Intraocular Lens | Class 3 | HQL |
| §886.3600 | Lens, Multifocal Intraocular | Class 3 | MFK |
| There is no relevant guidance developed at this time. |