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DIN EN ISO 11979-8

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011)

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Organization: DIN
Publication Date: 1 September 2015
Status: inactive
Page Count: 15
ICS Code (Ophthalmic equipment): 11.040.70
scope:

This part of ISO 11979 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants and transplants.

 

Document History

DIN EN ISO 11979-8
August 1, 2017
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)
A description is not available for this item.
DIN EN ISO 11979-8
April 1, 2016
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO/DIS 11979-8:2016); German and English version prEN ISO 11979-8:2016
A description is not available for this item.
DIN EN ISO 11979-8
September 1, 2015
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011)
This part of ISO 11979 specifies fundamental requirements for all types of intraocular lenses intended for surgical implantation into the anterior segment of the human eye, excluding corneal implants...
DIN EN ISO 11979-8
September 1, 2011
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd.1:2011)
A description is not available for this item.
DIN EN ISO 11979-8
August 1, 2009
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)
A description is not available for this item.
DIN EN ISO 11979-8/A1
January 1, 2009
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006); English version prEN ISO 11979-8:2008, Amendment 1
A description is not available for this item.
DIN EN ISO 11979-8
October 1, 2006
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006)
A description is not available for this item.
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References

This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
Published by ISO on October 15, 2008
This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO...
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 11979-2 - Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
Published by ISO on August 15, 2014
This part of ISO 11979 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/or...
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