ANSI Z80.29 : 2015

Superseded

View Superseded by

OPHTHALMICS - ACCOMODATIVE INTRAOCULAR LENSES

Available format(s)

Hardcopy , PDF

Superseded date

18-12-2020

Language(s)

English

Published date

01-01-2015

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 (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Status	Superseded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	ANSI Z80.29:2015(R2020)

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