EN ISO 11979-6:2014

SLOVENSKI STANDARD
01-januar-2015
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SIST EN ISO 11979-6:2008
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Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO
11979-6:2014)
Ophthalmische Implantate - Intraokularlinsen - Teil 6: Haltbarkeits- und
Transportprüfungen (ISO 11979-6:2014)
Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Durée de conservation et
stabilité pendant le transport (ISO 11979-6:2014)
Ta slovenski standard je istoveten z: EN ISO 11979-6:2014
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11979-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2014
ICS 11.040.70 Supersedes EN ISO 11979-6:2007
English Version
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and
transport stability testing (ISO 11979-6:2014)
Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Ophthalmische Implantate - Intraokularlinsen - Teil 6:
Durée de conservation et stabilité pendant le transport (ISO Haltbarkeits- und Transportprüfungen (ISO 11979-6:2014)
11979-6:2014)
This European Standard was approved by CEN on 28 June 2014.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-6:2014 E
worldwide for CEN national Members.

Contents
Page
Foreword .3
Foreword
This document (EN ISO 11979-6:2014) 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 2015, and conflicting national standards shall be withdrawn at the
latest by April 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11979-6:2007.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11979-6:2014 has been approved by CEN as EN ISO 11979-6:2014 without any modification.
INTERNATIONAL ISO
STANDARD 11979-6
Third edition
2014-10-01
Ophthalmic implants — Intraocular
lenses —
Part 6:
Shelf-life and transport stability
testing
Implants ophtalmiques — Lentilles intraoculaires —
Partie 6: Durée de conservation et stabilité pendant le transport
Reference number
ISO 11979-6:2014(E)
©
ISO 2014
ISO 11979-6:2014(E)
© ISO 2014
All rights reserved. Unless otherwise specified, 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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved

ISO 11979-6:2014(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Requirements . 1
4.1 General . 1
4.2 Materials and methods . 2
4.3 Product stability. 2
4.4 Package integrity . 4
4.5 Transport stability . 5
4.6 Results . 5
5 Test methods and sampling . 6
Annex A (informative) Shelf-life study example . 7
Annex B (informative) Tests for shelf-life studies .10
Bibliography .11
ISO 11979-6:2014(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 11979-6:2007), which has been technically
revised.
ISO 11979 consists of the following parts, under the general title Ophthalmic implants — Intraocular
lenses:
— Part 1: Vocabulary
— Part 2: Optical properties and test methods
— Part 3: Mechanical properties and test methods
— Part 4: Labelling and information
— Part 5: Biocompatibility
— Part 6: Shelf-life and transport stability testing
— Part 7: Clinical investigations
— Part 8: Fundamental requirements
— Part 9: Multifocal intraocular lenses
— Part 10: Phakic intraocular lenses
iv © ISO 2014 – All rights reserved

ISO 11979-6:2014(E)
Introduction
The purpose of a stability study is to ascertain that the properties of a product, in this case an intraocular
lens (IOL), remain within specified limits for a sufficiently long period of time under the influence of a
variety of environmental conditions.
The storage stability of the intraocular lens material is an important factor in the overall investigation
of a new lens material, a new combination of given lens materials, a new packaging material, or a new
manufacturing process. To assess this, a study of the ageing of the lenses in their containers is performed.
Changes in the composition and material, material suppliers, manufacturing conditions (including the
sterilization process), or the package design or material could affect the shelf-life and could therefore
necessitate renewed investigations. The need for studies of product stability, package integrity, and
transport stability can be assessed using ISO 14971.
The design of the stability tests should be based on the known properties of the material from which
the intraocular lens is made, and the recommendations for use of the intraocular lens. Knowledge of the
quantity and identity of extractable substances found after storage or accelerated ageing studies are of
importance in evaluating new intraocular lens materials.
On the basis of the information obtained, transport and storage conditions can be recommended that
will maintain the quality of the intraocular lens in relation to its safety, efficacy, and acceptability,
throughout the proposed shelf-life, i.e. during storage and distribution up until the moment of dispensing.
The results obtained are also used to determine the expiration date.
In practical terms, it is the stability of the material from which the intraocular lens is made that is
being tested, along with the integrity of the packaging that maintains the necessary environment of the
intraocular lens.
Stability studies for intraocular lenses are thus material specific, i.e. this type of study need not be
performed for more than one intraocular lens model for a given combination of IOL material(s), packaging
materials, and manufacturing processes.
INTERNATIONAL STANDARD ISO 11979-6:2014(E)
Ophthalmic implants — Intraocular lenses —
Part 6:
Shelf-life and transport stability testing
1 Scope
This part of ISO 11979 specifies tests by
...