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ANSI Z80.12 : 2007

Current
Current

The latest, up-to-date edition.

OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

Publisher

Optical Laboratories Association

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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Hardcopy - English
PDF - English

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