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

Status
Published
Publication Date
06-Oct-2020
Withdrawal Date
29-Apr-2021
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Start Date
07-Oct-2020
Completion Date
07-Oct-2020

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SLOVENSKI STANDARD
SIST EN ISO 11979-5:2020
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
SIST EN ISO 11979-5:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-5:2020

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SIST EN ISO 11979-5:2020


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.

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SIST EN ISO 11979-5:2020
EN ISO 11979-5:2020 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 11979-5:2020
EN ISO 11979-5:2020 (E)
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.

3

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SIST EN ISO 11979-5:2020

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SIST EN ISO 11979-5:2020
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
I
...

SLOVENSKI STANDARD
oSIST prEN ISO 11979-5:2019
01-september-2019
Očesni vsadki (implantati) - Intraokularne leče - 5. del: Biokompatibilnost (ISO/DIS
11979-5:2019)
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO/DIS 11979-
5:2019)
Ophthalmische Implantate - Intraokularlinsen - Teil 5: Biokompatibilität (ISO/DIS 11979-
5:2019)
Implants ophtalmiques - Lentilles intraoculaires - Partie 5: Biocompatibilité (ISO/DIS
11979-5:2019)
Ta slovenski standard je istoveten z: prEN ISO 11979-5
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 11979-5:2019 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 11979-5:2019

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oSIST prEN ISO 11979-5:2019
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11979-5
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2019-05-31 2019-08-23
Ophthalmic implants — Intraocular lenses —
Part 5:
Biocompatibility
Implants ophtalmiques — Lentilles intraoculaires —
Partie 5: Biocompatibilité
ICS: 11.040.70
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11979-5:2019(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2019

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oSIST prEN ISO 11979-5:2019
ISO/DIS 11979-5:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
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
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

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oSIST prEN ISO 11979-5:2019
ISO/DIS 11979-5:2019(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 . 3
5.3 Exhaustive extraction test . 4
5.4 Test for leach
...

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