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I.S. EN ISO 11979-5:2006

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

View Superseded by
withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
Available format(s)

Hardcopy , PDF

Withdrawn date

04-30-2021

Language(s)

English

Published date

01-01-2006

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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.

DevelopmentNote
Supersedes I.S. EN 13503-5. (08/2006)
DocumentType
Standard
Pages
36
PublisherName
National Standards Authority of Ireland
Status
Withdrawn
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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PDF - English
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