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BS EN ISO 11979-5:2006

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Ophthalmic implants. Intraocular lenses Biocompatibility
Available format(s)

Hardcopy , PDF

Superseded date

10-12-2020

Language(s)

English

Published date

06-30-2006

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements applying to biocompatibility
  evaluation of intraocular lenses
5 Physicochemical tests
6 Biological tests
Annex A (normative) Exhaustive extraction test
Annex B (normative) Test for leachables
Annex C (normative) Hydrolytic stability
Annex D (normative) Photostability test
Annex E (normative) Nd-YAG laser exposure test
Annex F (informative) Supplemental conditions of test for
                      local effects after implantation
Annex G (normative) Ocular implantation test
Bibliography

Specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. It also gives guidance on conducting an ocular implantation test.

Committee
CH/172/7
DevelopmentNote
Supersedes BS EN 13503-5 & 04/30103836 DC (06/2006)
DocumentType
Standard
Pages
36
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

ISO 10993-3:2014 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO 10993-2:2006 Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 11979-3:2012 Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO 10993-12:2012 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 11979-1:2006 Ophthalmic implants Intraocular lenses Part 1: Vocabulary
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 11979-2:2014 Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 10993-6:2016 Biological evaluation of medical devices Part 6: Tests for local effects after implantation

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