ONORM EN ISO 11979-5 : 2010

Name: ONORM EN ISO 11979-5 : 2010
Brand: ON

Withdrawn

View Superseded by

OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY

Withdrawn date

15-04-2021

Published date

12-01-2013

Publisher

Osterreichisches Normungsinstitut/Austrian Standards

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 ONORM EN 13503-5. (08/2006)
DocumentType	Standard
PublisherName	Osterreichisches Normungsinstitut/Austrian Standards
Status	Withdrawn
SupersededBy	ÖNORM EN ISO 11979-5:2021 04 15

Standards	Relationship
ISO 11979-5:2006	Identical
EN ISO 11979-5:2006	Identical
I.S. EN ISO 11979-5:2006	Identical
NS EN ISO 11979-5 : 1ED 2006	Identical
SN EN ISO 11979-5 : 2006	Identical
UNI EN ISO 11979-5 : 2006	Identical
DIN EN ISO 11979-5:2010-11	Identical
NBN EN ISO 11979-5 : 2006	Identical
UNE-EN ISO 11979-5:2007	Identical
BS EN ISO 11979-5:2006	Identical
NF EN ISO 11979-5 : 2006	Identical
NEN EN ISO 11979-5 : 2006	Identical
DIN EN ISO 11979-5 E : 2010	Identical

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