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ISO 11979-5

Ophthalmic Implants - Intraocular Lenses - Part 5: Biocompatibility

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Organization: ISO
Publication Date: 15 November 1999
Status: inactive
Page Count: 20
ICS Code (Ophthalmic equipment): 11.040.70
scope:

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 10993. 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 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 10993-11 - Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Published by ISO on September 1, 2017
This document specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
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...
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