ISO/TR 22979:2017
Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
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.
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Modifications to parent models
4.1 General
4.2 Modification levels
4.2.1 General
4.2.2 Level A modifications
4.2.3 Level B modifications
4.2.4 Level C modifications
4.2.5 Clinical investigation with multiple IOL models
5 Considerations for the assignment of modification level
5.1 General
5.2 Risk assessment
5.3 Special considerations
5.3.1 Phakic lenses
5.3.2 Anterior chamber lenses
5.3.3 Posterior chamber lenses intended for implantation in the sulcus
6 Modifications of optical design features
6.1 Optical design changes
6.2 Multifocal lenses (MIOL)
6.3 Toric lenses (TIOL)
6.4 Accommodating lenses (AIOL)
7 Modifications to the mechanical design
7.1 General
7.2 Mechanical analysis
8 Modifications to material
8.1 Interchanging IOL materials
8.2 New materials
Annex A (informative) Examples of modifications to a parent IOL model
Annex B (informative) Mechanical data analysis
Bibliography
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Modifications to parent models
4.1 General
4.2 Modification levels
4.2.1 General
4.2.2 Level A modifications
4.2.3 Level B modifications
4.2.4 Level C modifications
4.2.5 Clinical investigation with multiple IOL models
5 Considerations for the assignment of modification level
5.1 General
5.2 Risk assessment
5.3 Special considerations
5.3.1 Phakic lenses
5.3.2 Anterior chamber lenses
5.3.3 Posterior chamber lenses intended for implantation in the sulcus
6 Modifications of optical design features
6.1 Optical design changes
6.2 Multifocal lenses (MIOL)
6.3 Toric lenses (TIOL)
6.4 Accommodating lenses (AIOL)
7 Modifications to the mechanical design
7.1 General
7.2 Mechanical analysis
8 Modifications to material
8.1 Interchanging IOL materials
8.2 New materials
Annex A (informative) Examples of modifications to a parent IOL model
Annex B (informative) Mechanical data analysis
Bibliography