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ANSI Z80.7 : 2013

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

OPHTHALMIC OPTICS - INTRAOCULAR LENSES
Available format(s)

Hardcopy , PDF

Superseded date

02-13-2020

Language(s)

English

Published date

01-01-2013

Foreword
1 Scope and Purpose
2 Normative references
3 Vocabulary
4 Physical requirements
5 Optical requirements
6 Mechanical requirements
7 Biocompatibility requirements
8 Sterility/package integrity requirements
9 Shelf-life/shipping requirements
Annexes
A - Genotoxicity test
B - Maximization sensitization test
C - Ocular Implantation Test
D - Residual monomer determination - Methyl
    methacrylate
E - Bibliography

Pertains to monofocal intraocular lenses (IOLs) whose primary indication is the correction of aphakia.

Committee
Z80
DocumentType
Standard
Pages
21
PublisherName
Optical Laboratories Association
Status
Superseded
SupersededBy

ANSI Z80.12 : 2007 : R2017 OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES
ANSI Z80.13 : 2007 : R2012 OPHTHALMICS - PHAKIC INTRAOCULAR LENSES
ANSI Z80.13 : 2007 OPHTHALMICS - PHAKIC INTRAOCULAR LENSES
ANSI Z80.29 : 2015 OPHTHALMICS - ACCOMODATIVE INTRAOCULAR LENSES
ANSI Z80.13 : 2007 : R2017 OPHTHALMICS - PHAKIC INTRAOCULAR LENSES
ANSI Z80.30 : 2010 OPHTHALMICS - TORIC INTRAOCULAR LENSES
ANSI Z80.12 : 2007 OPHTHALMICS - MULTIFOCAL INTRAOCULAR LENSES

ASTM F 1585 : 2000 Standard Guide for Integrity Testing of Porous Barrier Medical Packages (Withdrawn 2006)
AAMI ISO 11134 : 1ED 93 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR VALIDATION AND ROUTINE CONTROL - INDUSTRIAL MOIST HEAT STERILIZATION
AAMI TIR19 : 1998 GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS
ANSI/AAMI/ISO 10993-3:2014 BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 3: TESTS FOR GENOTOXICITY, CARCINOGENICITY, AND REPRODUCTIVE TOXICITY
ANSI/AAMI/ISO 11135:2014 STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
ISO 11979-7:2014 Ophthalmic implants Intraocular lenses Part 7: Clinical investigations
ASTM F 1929 : 2015 : REDLINE Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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
AAMI ISO 14155 : 2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE
AAMI ISO 11137 : 94 AMD 1 2002 STERILIZATION OF HEALTH CARE PRODUCTS - REQUIREMENTS FOR THE VALIDATION AND ROUTINE CONTROL - RADIATION STERILIZATION
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 2248:1985 Packaging Complete, filled transport packages Vertical impact test by dropping
ISO 8318:2000 Packaging Complete, filled transport packages and unit loads Sinusoidal vibration tests using a variable frequency
AAMI ISO 11607 : 2ED 2000 PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES

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