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ISO 11979-5

Ophthalmic Implants - Intraocular Lenses - Part 5: Biocompatibility

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Organization: ISO
Publication Date: 1 June 2006
Status: inactive
Page Count: 32
ICS Code (Ophthalmic equipment): 11.040.70
scope:

This part of ISO 11979 specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.

Document History

ISO 11979-5
September 1, 2020
Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility
This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements...
ISO 11979-5
June 1, 2006
Ophthalmic Implants - Intraocular Lenses - Part 5: Biocompatibility
This part of ISO 11979 specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These...
ISO 11979-5
November 15, 1999
Ophthalmic Implants - Intraocular Lenses - Part 5: Biocompatibility
This part of ISO 11979 specifies particular requirements for the the biological evaluation of intraocular lenses (IOLs) which are in addition to the requirements outlined in the relevant parts of ISO...

References

This document references:
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 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...
This document references:
ISO 11979-3 - Ophthalmic Implants - Intraocular Lenses - Part 3: Mechanical Properties and Test Methods
Published by ISO on December 1, 2012
This part of ISO 11979 specifies requirements and test methods for certain mechanical properties of intraocular lenses (IOLs). It is applicable to all types of IOLs intended for implantation in the...
This document references:
ISO 10993-3 - Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Published by ISO on October 1, 2014
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following potentially...
This document references:
ISO 10993-2 - Biological evaluation of medical devices Part 2: Animal welfare requirements
Published by ISO on July 15, 2006
This part of ISO 10993 is aimed at those who commission, design and perform tests or evaluate data from animal tests undertaken to assess the biocompatibility of materials intended for use in medical...
This document references:
10993-10 - Biological evaluation of medical devices — Part 10: Tests for skin sensitization
Published by ISO on November 1, 2021
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —...
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...
This document references:
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 Z80.13 - For Ophthalmics – Phakic Intraocular Lenses
Published by ANSI on March 26, 2007
This standard applies to the processing of all prescription ophthalmic spectacle lenses in edged or assembled form. It is a processing guideline for optical laboratories applicable to prescription...
This document is referenced by:
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:
EN ISO 11979-1 - Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
Published by CEN on December 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 is referenced by:
ANSI Z80.27 - Ophthalmics – Implantable Glaucoma Devices
Published by ANSI on January 27, 2014
Scope and purpose The scope of this standard applies to devices that are implanted in the eye to treat glaucoma by facilitating aqueous outflow. The standard excludes glaucoma devices whose effect...
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