ANSI Z80.12 : 2007
Current
The latest, up-to-date edition.
OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES
Hardcopy , PDF
English
01-01-2017
Foreword
1 Scope and Purpose
2 Normative references
3 Definitions
4 Physical requirements
5 Optical requirements
6 Mechanical requirements
7 Biocompatibility requirements
8 Sterility/package integrity requirements
9 Shelf-life and transport stability requirements
10 Clinical evaluation
11 Labeling
Annexes
Annex A - Optical characterization
Annex B - Non-ocular implantation test
Annex C - Clinical investigation
Annex D - MIOL modifications
Annex E - Labeling for MIOLs
Annex F - Determination of sample sizes for the clinical investigation
Annex G - Functional performance
Annex H - Bibliography
Pertains to any ocular implant whose primary indication is the correction of aphakia and whose optic is designed to provide simultaneous distance and near vision.
| DocumentType |
Standard
|
| Pages |
44
|
| ProductNote |
Reconfirmed 2007
|
| PublisherName |
Optical Laboratories Association
|
| Status |
Current
|
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| ISO 11979-7:2014 | Ophthalmic implants Intraocular lenses Part 7: Clinical investigations |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| ANSI Z80.7 : 2013 | OPHTHALMIC OPTICS - INTRAOCULAR LENSES |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 11979-3:2012 | Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods |
| 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 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
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