ISO/TR 22979:2017
Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
OVERVIEW
ISO/TR 22979:2017 provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1?9] It addresses factors to be considered in the risk management process of modifications to anterior and posterior chamber IOLs in accordance with ISO 14971.[11] It also suggests methods of data analysis and interpretation that can be used to determine the need for a clinical investigation and its design.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2017 |
| No. of Pages | 22 |
| ICS Classification | 11.040.70 Ophthalmic equipment |
| Committee | ISO/TC 172/SC 7 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |