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ISO 11979-5

Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility

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Organization: ISO
Publication Date: 1 September 2020
Status: active
Page Count: 34
ICS Code (Ophthalmic equipment): 11.040.70
scope:

This document 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:
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 10993-6 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
Published by ISO on December 1, 2016
This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to...
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:
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 10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Published by ISO on January 1, 2021
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological...
This document references:
10993-17 - Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
Published by ISO on September 1, 2023
This document specifies the process and requirements for the toxicological risk assessment of medical device constituents. The methods and criteria used to assess whether exposure to a constituent is...
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:
ISO 10993-6 - Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
Published by ISO on December 1, 2016
This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to...
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:
BS EN ISO 11979-8 - Ophthalmic implants - Intraocular lenses Part 8: Fundamental requirements
Published by BSI on June 30, 2017
A description is not available for this item.
This document is referenced by:
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 is referenced by:
ISO 11979-8 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
Published by ISO on April 1, 2017
This document 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...
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