SIST EN ISO 11979-6:2008

SLOVENSKI STANDARD
SIST EN ISO 11979-6:2008
01-april-2008
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Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO
11979-6:2007)
Ophthalmische Implantate - Intraokularlinsen - Teil 6: Haltbarkeits- und
Transportprüfungen (ISO 11979-6:2007)
Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Durée de conservation et
stabilité pendant le transport (ISO 11979-6:2007)
Ta slovenski standard je istoveten z: EN ISO 11979-6:2007
ICS:
11.040.70
SIST EN ISO 11979-6:2008 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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EUROPEAN STANDARD
EN ISO 11979-6
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2007
ICS 11.040.70 Supersedes EN 13503-6:2002
English Version
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and
transport stability (ISO 11979-6:2007)
Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Ophthalmische Implantate - Intraokularlinsen - Teil 6:
Durée de conservation et stabilité pendant le transport (ISO Haltbarkeits- und Transportprüfungen (ISO 11979-6:2007)
11979-6:2007)
This European Standard was approved by CEN on 23 May 2007.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2007 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-6:2007: E
worldwide for CEN national Members.

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EN ISO 11979-6:2007 (E)





Foreword


This document (EN ISO 11979-6:2007) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" 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 January 2008, and conflicting national
standards shall be withdrawn at the latest by January 2008.

This document supersedes EN 13503-6:2002.

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, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United
Kingdom.


Endorsement notice

The text of ISO 11979-6:2007 has been approved by CEN as EN ISO 11979-6:2007 without any
modifications.

2

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INTERNATIONAL ISO
STANDARD 11979-6
Second edition
2007-07-15

Ophthalmic implants — Intraocular
lenses —
Part 6:
Shelf-life and transport stability
Implants ophtalmiques — Lentilles intraoculaires —
Partie 6: Durée de conservation et stabilité pendant le transport




Reference number
ISO 11979-6:2007(E)
©
ISO 2007

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ISO 11979-6:2007(E)
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ii © ISO 2007 – All rights reserved

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ISO 11979-6:2007(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. 4
4.6 Results . 5
5 Test methods and sampling . 5
Annex A (informative) Shelf-life study example. 6
Annex B (informative) Tests for shelf-life studies . 9
Bibliography . 10

© ISO 2007 – All rights reserved iii

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ISO 11979-6:2007(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 11979-6 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 11979-6:2002) 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
⎯ Part 7: Clinical investigations
⎯ Part 8: Fundamental requirements
⎯ Part 9: Multifocal intraocular lenses
⎯ Part 10: Phakic intraocular lenses
iv © ISO 2007 – All rights reserved

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ISO 11979-6:2007(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.
Stability studies of intraocular lenses allow the determination of the shelf-life and package suitability as well as
recommendations for transport and storage conditions.

© ISO 2007 – All rights reserved v

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INTERNATIONAL STANDARD ISO 11979-6:2007(E)

Ophthalmic implants — Intraocular lenses —
Part 6:
Shelf-life and transport stability
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 referenced documents are indispensable for the application of this document. 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 testing of medical devices — Tests for in vitro cytotoxicity
ISO 10993-12, Biological testing of medical devices — 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 14971, Medical devices — Application of risk management to medical devices
ISO/TR 22979, Ophthalmic implants — Intraocular lenses — Guidance on assessment of the need for clinical
investigation of intraocular lens design modifications
3 Terms and definitions
For the purposes of this document, the terms and definitions of 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.
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ISO 11979-6:2007(E)
The study shall demonstrate that the parameters assessed with regard to performance, safety and product
acceptability are within the original manufacturing specifications at the conclusion of the study.
In view of the fact that sufficiently long experience of storage of a new intraocular lens may not have been
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 used in the information on the product. 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. An accelerated study shall however always be verified by a real-time
study. The same product or a Level A modification of it (see ISO/TR 22979) shall be used in the real-time
study. The real-time study shall be started before the release of the new intraocular lens to the market. The
real-time study results always take precedence over the accelerated study results.
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 (see ISO 11979-1).
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, e.g. for possible changes to the storage solution for IOLs
stored in a solution. The methods selected 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 (e.g. dioptric
power, imaging quality and spectral transmission can all be measured on the same IOL), thereby reducing the
total number of intraocular lenses 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.
The shelf-life of an IOL shall be established based on data from at least three lots of finished IOLs (low,
medium and high dioptric power ranges, each range comprising one or more dioptric powers), both for real-
time studies and accelerated studies.
Based on a manufacturer’s experience with the IOL material(s), packaging material(s), sterilization process
and packaging process, a manufacturer’s risk analysis can support the adequacy to perform a study on only
one lot of product.
4.3.2 Real-time shelf-life study
4.3.2.1 Test parameters
The following parameters shall be considered for inclusion when a real-time shelf-life study i
...