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ANSI Z80.30 : 2010

Current
Current

The latest, up-to-date edition.

OPHTHALMICS - TORIC INTRAOCULAR LENSES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2010

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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