PD ISO/TR 22979:2017
Current
The latest, up-to-date edition.
Ophthalmic implants. Intraocular lenses. Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
Hardcopy , PDF
English
21-09-2017
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Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Modifications to parent models
5 Considerations for the assignment of modification
level
6 Modifications of optical design features
7 Modifications to the mechanical design
8 Modifications to material
Annex A (informative) - Examples of modifications
to a parent IOL model
Annex B (informative) - Mechanical data analysis
Bibliography
Gives guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).
| Committee |
CH/172/7
|
| DocumentType |
Standard
|
| Pages |
30
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
This document provides guidance on the application of all parts of the ISO11979 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 ISO14971 .[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.
| Standards | Relationship |
| ISO/TR 22979:2017 | Identical |
| ISO 11979-10:2006 | Ophthalmic implants Intraocular lenses Part 10: Phakic intraocular lenses |
| ISO 11979-7:2014 | Ophthalmic implants Intraocular lenses Part 7: Clinical investigations |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| ISO 11979-3:2012 | Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods |
| ISO 11979-9:2006 | Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses |
| ISO 11979-8:2017 | Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements |
| ISO 11979-1:2006 | Ophthalmic implants Intraocular lenses Part 1: Vocabulary |
| ISO 11979-4:2008 | Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information |
| ISO 11979-2:2014 | Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods |
| ISO 11979-5:2006 | Ophthalmic implants Intraocular lenses Part 5: Biocompatibility |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| ISO 11979-6:2014 | Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing |
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