NEN - NPR-ISO/TR 22979
Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
inactive
| Organization: | NEN |
| Publication Date: | 1 March 2006 |
| Status: | inactive |
| Page Count: | 26 |
| ICS Code (Ophthalmic equipment): | 11.040.70 |
scope:
This Technical Report 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
June 1, 2017
Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
NPR-ISO/TR 22979 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs). It addresses factors to be considered in the risk...
NPR-ISO/TR 22979
March 1, 2006
Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
This Technical Report 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...