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download between 0-24 hoursReleased: 2017
ISO/TR 22979:2017
ISO/TR 22979:2017-Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
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| Standard´s number: | ISO/TR 22979:2017 |
| Pages: | 22 |
| Edition: | 2 |
| Released: | 2017 |
| Language: | English |
DESCRIPTION
ISO/TR 22979:2017
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.