SIST EN ISO 11979-6:2015
(Main)Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2014)
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2014)
This part of ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their
final packaging can be determined. These tests include procedures to establish the stability of IOLs in
distribution and storage.
Ophthalmische Implantate - Intraokularlinsen - Teil 6: Haltbarkeits- und Transportprüfungen (ISO 11979-6:2014)
Dieser Teil von ISO 11979 legt Prüfverfahren fest, mit denen die Haltbarkeit steriler Intraokularlinsen (IOLs) in ihrer Endverpackung bestimmt werden kann. Diese Prüfverfahren beinhalten Verfahren zur Bestimmung der Haltbarkeit von IOLs während Auslieferung und Lagerung.
Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Durée de conservation et stabilité pendant le transport (ISO 11979-6:2014)
L'ISO 11979-6:2014 spécifie les essais permettant de déterminer la durée de conservation des lentilles intraoculaires (LIO) stériles dans leur emballage final. Ces essais incluent des modes opératoires permettant de vérifier la stabilité des LIO pendant la distribution et le stockage.
Očesni vsadki (implantati) - Intraokularne leče - 6. del: Rok uporabnosti in obstojnost pri prevozu (ISO 11979-6:2014)
Ta del standarda ISO 11979 določa preskuse, s katerimi je mogoče določiti rok uporabnosti sterilnih intraokularnih leč (IOL) v končni embalaži. Ti preskusi vključujejo postopke za ugotavljanje obstojnosti intraokularnih leč pri prevozu in shranjevanju.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11979-6:2015
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
SIST EN ISO 11979-6:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11979-6:2015
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SIST EN ISO 11979-6:2015
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.
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SIST EN ISO 11979-6:2015
EN ISO 11979-6:2014 (E)
Contents
Page
Foreword .3
2
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SIST EN ISO 11979-6:2015
EN ISO 11979-6:2014 (E)
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.
3
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SIST EN ISO 11979-6:2015
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SIST EN ISO 11979-6:2015
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
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SIST EN ISO 11979-6:2015
ISO 11979-6:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© 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
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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
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SIST EN ISO 11979-6:2015
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 2014 – All rights reserved iii
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SIST EN ISO 11979-6:2015
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
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SIST EN ISO 11979-6:2015
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.
© ISO 2014 – All rights reserved v
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SIST EN ISO 11979-6:2015
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SIST EN ISO 11979-6:2015
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 which the shelf-life of sterile intraocular lenses (IOLs) in their
final packaging can be determined. These tests include procedures to establish the stability of IOLs in
distribution and storage.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 11979-1, Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary
ISO 10993-5, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ISO 10993-12, Biological evaluation of medical devices — Part 12: Sample preparation and reference
materials
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials,
sterile barrier systems and packaging systems
ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for
forming, sealing and assembly processes
ISO 14971, Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11979-1 apply.
4 Requirements
4.1 General
If, following a risk analysis in accordance with ISO 14971, it is found that a product stability study, a
package integrity study, and/or a transport stability study are needed, this part of ISO 11979 shall apply
to the planning and conduct of these studies.
A study protocol shall be developed prior to initiation of the study.
The study results shall demonstrate that the parameters measured with regard to performance, safety,
and product acceptability are within the finished product specifications, when available. In cases where
there are no finished product specifications, then the parameters measured shall remain within the
limits of the applicable parts of ISO 11979. If there exists neither finished product specifications nor
applicable limits specified within ISO 11979, then a comparison to time zero product shall be performed.
© ISO 2014 – All rights reserved 1
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SIST EN ISO 11979-6:2015
ISO 11979-6:2014(E)
In view of the fact that an intraocular lens may not have sufficient storage assessments accumulated by
the time it is brought to the market, the results of accelerated tests (see 4.3.2) are acceptable for initial
labelling purposes, i.e. to establish a shelf-life to be indicated on the product labelling. A maximum of
five years of shelf-life can be claimed by a real-time study or an accelerated study regardless of material
used in the intraocular lens. However, an accelerated study shall always be verified by a real-time study,
and the real-time study results shall always take precedence over the accelerated study results. The
same product or a Level A modification of it (see ISO/TR 22979) shall be used in the real-time study, and
the real-time study shall be started before the release of the new intraocular lens into the market.
In case a manufacturer wishes to maintain the possibility of resterilizing finished intraocular lens
lots, the finished intraocular lens lot(s) used in the stability study shall have undergone the maximum
number of sterilization cycles allowed under the manufacturer’s procedures.
4.2 Materials and methods
4.2.1 Test samples
The studies shall be performed using IOLs from finished intraocular lens lots. The proposed sample
sizes are described in Annex A.
4.2.2 Methods
Suitable methods shall be chosen for any tests contained in the study protocol. The methods selected
shall be recorded. Annex B contains suggested tests. Due to the variation in product and package
materials and design, other tests could be more appropriate. The methods selected, other than those
specified in Annex B, shall be recorded and the details of validation for each test method, demonstrating
the capability of the method, shall also be documented.
In certain cases, more than one of the tests listed in Annex B can be performed on a single IOL, thereby
reducing the total number of IOLs required.
4.3 Product stability
4.3.1 General
If the risk analysis in accordance with ISO 14971 shows a need for a shelf-life study, the following shall
apply. The rationale for choice of tests shall be documented in the risk management plan.
For both real-time and accelerated testing, finished IOLs (or finished injector systems with IOLs) shall
be us
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