ANSI Z80.30 : 2010
Current
The latest, up-to-date edition.
OPHTHALMICS - TORIC INTRAOCULAR LENSES
Hardcopy , PDF
English
01-01-2010
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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
A - Dioptric power and image quality assessment
B - Guidance on additional clinical requirements
for toric IOLs
C - Wavefront sensor test methods for toric IOL
dioptric power and image quality measurement
D - Bibliography
Pertains to any monofocal intraocular lens (IOL) whose primary indication is the reduction of astigmatism either with the correction of aphakia or the modification of the refractive power of a phakic eye.
| Committee |
Z80
|
| DocumentType |
Standard
|
| Pages |
39
|
| PublisherName |
Optical Laboratories Association
|
| Status |
Current
|
| Supersedes |
| 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 |
| ANSI Z80.28 : 2017 | OPHTHALMICS - METHODS OF REPORTING OPTICAL ABERRATIONS OF EYES |
| 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 15367-1:2003 | Lasers and laser-related equipment Test methods for determination of the shape of a laser beam wavefront Part 1: Terminology and fundamental aspects |
| 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 |
| CFR 21(PTS1-99) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 1-99 |
| ISO 18369-3:2017 | Ophthalmic optics — Contact lenses — Part 3: Measurement methods |
| 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 15367-2:2005 | Lasers and laser-related equipment Test methods for determination of the shape of a laser beam wavefront Part 2: Shack-Hartmann sensors |
| 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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