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ANSI Z80.13 : 2007 : R2012

Current
Current

The latest, up-to-date edition.

OPHTHALMICS - PHAKIC INTRAOCULAR LENSES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

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 2012
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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