ANSI Z80.13 : 2007 : R2017
Current
The latest, up-to-date edition.
OPHTHALMICS - PHAKIC INTRAOCULAR LENSES
Hardcopy , PDF
English
01-01-2017
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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
10 Clinical investigation plan
11 Labeling
Annexes
Annex A - Mechanical characterization and testing
of phakic IOLs
Annex B - Non-ocular implantation test
Annex C - Ocular implantation test
Annex D - Clinical guidance
Annex E - Statistical sample size considerations
Annex F - Bibliography
Pertains to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye. It does not include IOLs used to correct presbyopia or astigmatism.
| Committee |
Z80
|
| DocumentType |
Standard
|
| Pages |
44
|
| ProductNote |
Reconfirmed 2017
|
| PublisherName |
Optical Laboratories Association
|
| Status |
Current
|
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| 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 8599:1994 | Optics and optical instruments Contact lenses Determination of the spectral and luminous transmittance |
| 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 11979-6:2014 | Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing |
| ISO 10993-6:2016 | Biological evaluation of medical devices Part 6: Tests for local effects after implantation |
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