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ISO 11979-7

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia

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Organization: ISO
Publication Date: 1 March 2018
Status: active
Page Count: 50
ICS Code (Ophthalmic equipment): 11.040.70
scope:

This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia

Document History

11979-7
January 1, 2024
Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.
ISO 11979-7
March 1, 2018
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia
ISO 11979-7
September 1, 2014
Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations
This part of ISO 11979 specifies particular requirements for clinical investigations for posterior and anterior chamber intraocular lenses (IOLs).
ISO 11979-7
January 15, 2012
Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations AMENDMENT 1
A description is not available for this item.
ISO 11979-7
May 1, 2006
Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations
This part of ISO 11979 specifies particular requirements for clinical investigations for posterior and anterior chamber monofocal intraocular lenses (IOLs) for the correction of aphakia.
ISO 11979-7
April 15, 2001
Ophthalmic Implants - Intraocular Lenses - Part 7: Clinical Investigations
This part of ISO 11979 specifies particular requirements for clinical investigation protocols for posterior and anterior chamber monofocal intraocular lenses (IOLs) for the correction of...
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References

This document references:
ISO 11979-10 - Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
Published by ISO on March 1, 2018
This document specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power. There are three main...
This document references:
ISO 11979-1 - Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
Published by ISO on November 1, 2018
This document defines terms applicable to intraocular lenses, and to the methods used to evaluate them. NOTE Terms are listed in the alphabetical order of the English terms in the English version of...
This document references:
ISO TR 22979 - Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
Published by ISO on May 1, 2017
This document provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1-9] It addresses factors to be considered in the...
This document references:
ISO 11979-1 - Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
Published by ISO on November 1, 2018
This document defines terms applicable to intraocular lenses, and to the methods used to evaluate them. NOTE Terms are listed in the alphabetical order of the English terms in the English version of...
This document references:
ISO 11979-10 - Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes
Published by ISO on March 1, 2018
This document specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power. There are three main...
This document references:
ISO 14155 - Clinical investigation of medical devices for human subjects — Good clinical practice
Published by ISO on July 1, 2020
This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or...
This document references:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
This document references:
ISO TR 22979 - Ophthalmic implants - Intraocular lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
Published by ISO on May 1, 2017
This document provides guidance on the application of all parts of the ISO 11979 series of International Standards for intraocular lenses (IOLs).[1-9] It addresses factors to be considered in the...
This document is referenced by:
ANSI Z80.12 - Ophthalmics – Multifocal Intraocular Lenses
Published by ANSI on March 26, 2007
This standard applies to any ocular implant whose primary indication is the correction of aphakia and whose optic is designed to provide simultaneous distance and near vision. For the purposes of...
This document is referenced by:
ANSI Z80.29 - Ophthalmics – Accommodative Intraocular Lenses
Published by ANSI on May 28, 2015
Scope and purpose This standard applies to any ocular implant whose primary indication is the correction of aphakia and is designed to provide vision over a continuous range of distances by affecting...
This document is referenced by:
ANSI Z80.7 - Ophthalmic Optics – Intraocular Lenses
Published by ANSI on July 29, 2013
This standard applies to monofocal intraocular lenses (IOLs) whose primary indication is the correction of aphakia. This standard addresses the vocabulary, optical properties and test methods,...
This document is referenced by:
ANSI Z80.30 - Ophthalmics – Toric Intraocular Lenses
Published by ANSI on June 18, 2018
Scope and purpose This standard applies to any monofocal intraocular lens (IOL) whose primary indication is the reduction of astigmatism either with the correction of aphakia or the modification of...
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