ANSI Z80.29 : 2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
OPHTHALMICS - ACCOMODATIVE INTRAOCULAR LENSES
Hardcopy , PDF
12-18-2020
English
01-01-2015
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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 (normative) - Optical characterization
Annex B (informative) - Clinical investigation
Annex C (informative) - Labeling for AIOLs
Annex D (informative) - Determination of sample sizes for
the clinical investigation
Annex E (informative) - Bibliography
Pertains to any ocular implant whose primary indication is the correction of aphasia and is designed to provide vision over a continuous range of distances by affecting a change in the mergence power of the eye resulting from the implant design that changes eye optical power or implant position in response to a stimulus.
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
Optical Laboratories Association
|
| Status |
Superseded
|
| SupersededBy |
| 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 11979-9:2006 | Ophthalmic implants Intraocular lenses Part 9: Multifocal intraocular lenses |
| ISO 11979-1:2006 | Ophthalmic implants Intraocular lenses Part 1: Vocabulary |
| 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 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
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