EN ISO 11979-5:2020
(Main)Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
This document specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.
Ophthalmische Implantate - Intraokularlinsen - Teil 5: Biokompatibilität (ISO 11979-5:2020)
Dieses Dokument legt die besonderen Anforderungen an die Bewertung der Biokompatibilität von Materialien für Intraokularlinsen (IOLs) sowie der bei deren Herstellung angewendeten Verfahren bzw. Bedingungen fest. Diese Anforderungen beinhalten die Bewertung der physikalisch-chemischen Eigen-schaften, die für die Biokompatibilität von Belang sind. Zudem gibt es eine Anleitung zur Durchführung einer Untersuchung zur intraokularen Implantation.
Implants ophtalmiques - Lentilles intraoculaires - Partie 5: Biocompatibilité (ISO 11979-5:2020)
Le présent document spécifie des exigences particulières relatives à l'évaluation de la biocompatibilité des matériaux des lentilles intraoculaires (LIO), y compris les conditions de traitement liées à leur fabrication. Ces exigences comprennent l'évaluation des propriétés physicochimiques relatives à la biocompatibilité. Le présent document donne également des recommandations relatives à la réalisation d'un essai d'implantation oculaire.
Očesni vsadki (implantati) - Intraokularne leče - 5. del: Biokompatibilnost (ISO 11979-5:2020)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-december-2020
Nadomešča:
SIST EN ISO 11979-5:2006
Očesni vsadki (implantati) - Intraokularne leče - 5. del: Biokompatibilnost (ISO
11979-5:2020)
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)
Ophthalmische Implantate - Intraokularlinsen - Teil 5: Biokompatibilität (ISO 11979-
5:2020)
Implants ophtalmiques - Lentilles intraoculaires - Partie 5: Biocompatibilité (ISO 11979-
5:2020)
Ta slovenski standard je istoveten z: EN ISO 11979-5:2020
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 11979-5
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2020
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11979-5:2006
English Version
Ophthalmic implants - Intraocular lenses - Part 5:
Biocompatibility (ISO 11979-5:2020)
Implants ophtalmiques - Lentilles intraoculaires - Ophthalmische Implantate - Intraokularlinsen - Teil 5:
Partie 5: Biocompatibilité (ISO 11979-5:2020) Biokompatibilität (ISO 11979-5:2020)
This European Standard was approved by CEN on 22 September 2020.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-5:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 11979-5:2020) has been prepared by Technical Committee ISO/TC 172 "Optics
and photonics" in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” the
secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by April 2021, and conflicting national standards shall be
withdrawn at the latest by April 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11979-5:2006.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11979-5:2020 has been approved by CEN as EN ISO 11979-5:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 11979-5
Third edition
2020-09
Ophthalmic implants — Intraocular
lenses —
Part 5:
Biocompatibility
Implants ophtalmiques — Lentilles intraoculaires —
Partie 5: Biocompatibilité
Reference number
ISO 11979-5:2020(E)
©
ISO 2020
ISO 11979-5:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO 11979-5:2020(E)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements applying to biocompatibility evaluation of intraocular lenses .2
5 Physicochemical tests. 3
5.1 General . 3
5.2 Physical/Chemical description . 4
5.3 Exhaustive extraction test . 4
5.4 Test for leachables . 4
5.5 Test for hydrolytic stability . 4
5.6 Photostability test . 5
5.7 Nd-YAG laser exposure test . 6
5.8 Evaluation of insoluble inorganics . 6
6 Biological tests . 7
6.1 General . 7
6.2 Test for cytotoxicity. 7
6.3 Tests for sensitization . 7
6.4 Tests for genotoxicity . 7
6.5 Test for local effects . 8
6.6 Ocular implantation test . 8
Annex A (normative) Exhaustive extraction test . 9
Annex B (normative) Test for leachables .13
Annex C (normative) Hydrolytic stability .15
Annex D (normative) Photostability test .18
Annex E (normative) Nd-YAG laser exposure test .20
Annex F (normative) Supplemental conditions of test for local effects after implantation .22
Annex G (normative) Ocular implantation test .23
Bibliography .27
ISO 11979-5:2020(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 7, Ophthalmic optics and instruments, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 170, Ophthalmic optics, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This third edition cancels and replaces the second edition (ISO 11979-5:2006), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— correction and addition of references throughout the document;
— added more specific guidance on risk-based approach throughout the document;
— added requirement to use state of the art analytical methods;
— update of apparatus lists where applicable;
— clarification of test material in Tables 1 and 2, reference to ISO/TR 22979 when the IOL is a
modification of a parent IOL and requirement for a biological evaluation plan added to Clause 4;
— combination and re-writing of physicochemical test methods and their objectives in Table 3 of 5.1;
— added requirement for physical/chemica
...
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