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immediate downloadReleased: 2017-09-21
PD 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 number: | PD ISO/TR 22979:2017 |
| Pages: | 30 |
| Released: | 2017-09-21 |
| ISBN: | 978 0 580 85343 2 |
| Status: | Standard |
DESCRIPTION
PD ISO/TR 22979:2017
This standard PD ISO/TR 22979:2017 Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications is classified in these ICS categories:
- 11.040.70 Ophthalmic equipment
This document 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.