• There are no items in your cart

I.S. EN ISO 11979-5:2020

Current
Current

The latest, up-to-date edition.

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-26-2020

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 (normative) Supplemental conditions of test for local effects after implantation
Annex G (normative) Ocular implantation test
Bibliography

This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them.

Committee
ISO/TC 172
DocumentType
Standard
Pages
44
ProductNote
The date of any NSAIprevious adoption may not matchthe date of its original CEN/CENELEC document.<br>
PublisherName
National Standards Authority of Ireland
Status
Current
Supersedes

Standards Relationship
EN ISO 11979-5:2020 Identical
ISO 11979-5:2020 Identical

View more information
US$58.10
Excluding Tax where applicable

Access your standards online with a subscription

Features

  • Simple online access to standards, technical information and regulations.

  • Critical updates of standards and customisable alerts and notifications.

  • Multi-user online standards collection: secure, flexible and cost effective.