DSF/ISO/TR 22979
Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
pending
| Organization: | DS |
| Status: | pending |
| Page Count: | 25 |
| ICS Code (Ophthalmic equipment): | 11.040.70 |
scope:
ISO/TR 22979:2005 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.
Document History
October 15, 2015
Ophthalmic implants – Intraocular lenses – Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ISO/TR 22979:2005 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...
DSF/ISO/TR 22979
Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
ISO/TR 22979:2005 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...