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Standards Referenced in ANSI Z80.35

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ANSI Z80.7 2013 Edition, July 29, 2013
Ophthalmic Optics – Intraocular Lenses
Includes all amendments and changes through Reaffirmation Notice , 2018

ANSI Z80.7

2013 Edition, July 29, 2013

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Ophthalmic Optics – Intraocular Lenses
Includes all amendments and changes through Reaffirmation Notice , 2018
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ISO 10993-2 2nd Edition, July 15, 2006
Biological evaluation of medical devices Part 2: Animal welfare requirements

ISO 10993-2

2nd Edition, July 15, 2006

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Biological evaluation of medical devices Part 2: Animal welfare requirements
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ISO 10993-6 3rd Edition, December 1, 2016
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

ISO 10993-6

3rd Edition, December 1, 2016

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Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
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ISO 11979-1 4th Edition, November 2018
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary

ISO 11979-1

4th Edition, November 2018

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Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
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ISO 11979-2 2nd Edition, August 15, 2014
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods

ISO 11979-2

2nd Edition, August 15, 2014

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Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
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ISO 11979-3 3rd Edition, December 1, 2012
Ophthalmic Implants - Intraocular Lenses - Part 3: Mechanical Properties and Test Methods

ISO 11979-3

3rd Edition, December 1, 2012

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Ophthalmic Implants - Intraocular Lenses - Part 3: Mechanical Properties and Test Methods
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ISO 11979-4 FRENCH 2nd Edition, December 1, 2008
French Language - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION
(Document Language: French)
Includes all amendments and changes through Amendment 1, October 1, 2012

ISO 11979-4 FRENCH

2nd Edition, December 1, 2008

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French Language - OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 4: LABELLING AND INFORMATION
Includes all amendments and changes through Amendment 1, October 1, 2012
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ISO 11979-5 FRENCH 2nd Edition, June 1, 2006
Implants ophtalmiques - Lentilles intraoculaires - Partie 5: Biocompatibilité
(Document Language: French)

ISO 11979-5 FRENCH

2nd Edition, June 1, 2006

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Implants ophtalmiques - Lentilles intraoculaires - Partie 5: Biocompatibilité
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ISO 11979-7 FRENCH 4th Edition, March 2018
Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques de lentilles intraoculaires pour la correction de l'aphakie
(Document Language: French)

ISO 11979-7 FRENCH

4th Edition, March 2018

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Implants ophtalmiques - Lentilles intraoculaires - Partie 7: Investigations cliniques de lentilles intraoculaires pour la correction de l'aphakie
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ISO 11979-8 3rd Edition, April 2017
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements

ISO 11979-8

3rd Edition, April 2017

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Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
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ISO 11979-9 1st Edition, September 1, 2006
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
Includes all amendments and changes through Amendment 1, August 15, 2014

ISO 11979-9

1st Edition, September 1, 2006

Complete Document
 
OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 9: MULTIFOCAL INTRAOCULAR LENSES
Includes all amendments and changes through Amendment 1, August 15, 2014
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ISO 14155-1 1st Edition, February 15, 2003
Clinical Investigation of Medical Devices for Human Subjects - Part 1: General Requirements

ISO 14155-1

1st Edition, February 15, 2003

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Clinical Investigation of Medical Devices for Human Subjects - Part 1: General Requirements
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ENGLISH * W/D S/S BY ISO 14155
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ISO 14155-2 1st Edition, May 15, 2003
Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans

ISO 14155-2

1st Edition, May 15, 2003

Complete Document
 
Clinical Investigation of Medical Devices for Human Subjects - Part 2: Clinical Investigation Plans
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ENGLISH * W/D S/S BY ISO 14155
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