SIST EN 13503-6:2003

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Ophthalmische Implantate - Intraokularlinsen - Teil 6: Haltbarkeits-und Transportprüfungen (ISO 11979-6:2002,modifiziert)Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Durée de conservation et stabilité pendant le transport (ISO 11979-6:2002,modifié)Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability (ISO 11979-6:2002,modified)11.040.70Oftalmološka opremaOphthalmic equipmentICS:Ta slovenski standard je istoveten z:EN 13503-6:2002SIST EN 13503-6:2003en01-marec-2003SIST EN 13503-6:2003SLOVENSKI
STANDARD



SIST EN 13503-6:2003



EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13503-6November 2002ICS 11.040.70English versionOphthalmic implants - Intraocular lenses - Part 6: Shelf-life andtransport stability (ISO 11979-6:2002,modified)Implants ophtalmiques - Lentilles intraoculaires - Partie 6:Durée de conservation et stabilité pendant le transport (ISO11979-6:2002,modifié)Ophthalmische Implantate - Intraokularlinsen - Teil 6:Haltbarkeits-und Transportprüfungen (ISO 11979-6:2002,modifiziert)This European Standard was approved by CEN on 19 August 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the 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 translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2002 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13503-6:2002 ESIST EN 13503-6:2003



EN 13503-6:2002 (E)2ForewordThe text of the International Standard from Technical Committee ISO/TC 172 "Ophthalmic optics and instruments"of the International Organization for Standardization (ISO) has been taken over as a European Standard byTechnical 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 orby endorsement, at the latest by May 2003, and conflicting national standards shall be withdrawn at the latest byMay 2003.European Standard EN 13503 was developed by CEN/TC 170, Ophthalmic optics, in cooperation withISO/TC 172/SC 7, Ophthalmic optics and instruments, and is published in several parts under the general titleOphthalmic implants - Intraocular lenses:¾ Part 1: Vocabulary¾ Part 2: Optical properties and test methods¾ Part 3: Mechanical properties and test methods¾ Part 4: Labelling and information¾ Part 5: Biocompatibility¾ Part 6: Shelf-life and transport stability¾ Part 7: Clinical investigations¾ Part 8: Fundamental requirementsEN 13503 is the modified ISO 11979. The main difference between both series of standards is that ISO 11979 isbased on the reference to ISO 14155 Clinical investigation of medical devices while EN 13503 is based on thereference to EN 540 Clinical investigation of medical devices for human subjects.Modifications of ISO 11979-6 are indicated as follows:¾ text which has been deleted is striked out;¾ text which has been changed or added is underlined.Annex A is normative and annexes B, C and D are informative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Spain,Sweden, Switzerland and the United Kingdom.Endorsement noticeThe text of the International Standard ISO 11979-6:2002 has been approved by CEN as a European Standard withagreed common modifications as given in the foreword and indicated in the text by strike-out and underlining.SIST EN 13503-6:2003



EN 13503-6:2002 (E)3IntroductionThe purpose of a stability study is to ascertain that the properties of the intraocular lens (IOL) remain withinspecified 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 lensmaterial, a new combinations 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 sterilizationprocess), or the package design or material may affect the shelf-life and may therefore necessitate renewedinvestigations.The design of the stability tests should be based on the known properties of the material from which the intraocularlens is made, and the recommendations for use of the intraocular lens. Knowledge of the quantity and identity ofextractable substances found after storage or accelerated ageing studies is of importance in evaluating newintraocular lens materials.On the basis of the information obtained, transport and storage conditions can be recommended that will maintainthe 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 todetermine the expiration date.In practical terms, it is the stability of the material from which the intraocular lens is made that is being tested, alongwith the integrity of the packaging that maintains the necessary environment of the intraocular lens. Stability studiesfor intraocular lenses are thus material specific, i.e. this type of study needs not to be performed for more than oneintraocular lens model for a given combination of IOL material(s), packaging materials, and manufacturingprocesses.Stability studies of intraocular lenses will allow the determination of the shelf-life and package suitability, as well asrecommendations for transport and storage conditions.NOTE
It always was and still is the intention of the Technical Committees ISO/TC 172/SC 7 and CEN/TC 170 to prepareidentical ISO and CEN (European Committee for Standardization) Standards on intraocular lenses. However, during the prepa-ration of part 7 of this series, problems were encountered with normative references to the existing ISO 14155 and EN 540horizontal standards on clinical investigation of medical devices, which are similar but not identical.ISO and CEN principles concerning normative references made it impossible to continue the preparation of identicalInternational and European Standards on the clinical investigation of intraocular lenses. As a result, two different standardsseries have had to be prepared. It is the intention of ISO/TC 172/SC 7 and CEN/TC 170 to revise these standards with the goalto ultimately have identical ones as soon as identical ISO and CEN horizontal standards on clinical investigations becomeavailable.1 ScopeThis part of EN 13503 ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in theirfinal packaging can be determined. These tests include procedures to establish the stability of IOLs in distributionand storage.2 Normative referencesThis European Standard incorporates by dated or undated reference, provisions from other publications. Thesenormative references are cited at the appropriate places in the text and the publications are listed hereafter. Fordated references, subsequent amendments to or revisions of any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).SIST EN 13503-6:2003



EN 13503-6:2002 (E)4The following normative documents contain provisions which, through reference in this text, constitute provisions ofthis part of ISO 11979. For dated references, subsequent amendments to, or revisions of, any of these publicationsdo not apply. However, parties to agreements based on this part of ISO 11979 are encouraged to investigate thepossibility of applying the most recent editions of the normative documents indicated below. For undatedreferences, the latest edition of the normative document referred to applies. Members of IEC and ISO maintainregisters of currently valid International Standards.EN 13503-3ISO 11979-3:1999, Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and testmethods (ISO 11979-3:1999, modified).EN 22248, Packaging – Complete, filled transport packages – Vertical impact test by dropping (ISO 2248:1985)EN ISO 8318, Packaging – Complete, filled transport packages and unit loads – Sinusoidal vibration tests using avariable frequency (ISO 8318:2000).EN ISO 11979-1:1999, Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:1999).ISO 11607:1997, Packaging for terminally sterilized medical devices.3 Terms and definitionsFor the purposes of this part of EN 13503 ISO 11979, the terms and definitions given in EN ISO 11979-1:1999 andthe following apply.3.1device history recordcompilation of records containing the production history3.2finished intraocular lens lotall units of an intraocular lens which have undergone a single series of manufacturing operations including thesterilization operation and which are identified on a single device history recordNOTESome definitions of EN ISO 11979-1, relevant to this part of EN 13503 ISO 11979, are reproduced in annex D.4 Requirements4.1 GeneralA study protocol shall be developed prior to initiation of the study.The study shall demonstrate that the parameters assessed with regard to efficacy, safety and product acceptabilityare within the original manufacturing specifications at the conclusion of the study.NOTE
In view of the fact that sufficiently long experience of storage of a new intraocular lens may not have beenaccumulated by the time it is brought to the market, the results of accelerated tests are acceptable. A test in real-time should becarried out under certain conditions (see 4.3.2) to confirm the accelerated shelf-life study.A maximum of five years of shelf-life should be claimed by a real-time study or an accelerated study regardless ofmaterial used in the intraocular lens. In the case where a manufacturer wishes to maintain the possibility toresterilize finished intraocular lens lots, the finished intraocular lens lot(s) used in the stability study shall haveundergone the maximum number of sterilization cycles allowed under the manufacturer’s procedures.SIST EN 13503-6:2003



EN 13503-6:2002 (E)54.2 Materials and methods4.2.1 Test samplesThe manufacturing lot(s) used for the stability study shall be representative for normally produced manufacturinglots, and be packaged in the manner intended for marketing.NOTE 1The number of finished intraocular lens lots and the dioptre range of the test samples depend on whether theintraocular lenses under study are made of new or known materials (see annex A).The number of intraocular lens lots to be studied shall be in accordance with the provisions of annex A.NOTE 2In certain cases, more than one of the tests listed in annex A may be performed on a single IOL (e.g. dioptric power,imaging quality and spectral transmission may all be measured on the same IOL), thereby reducing the total number ofintraocular lenses required.4.2.2 Analytical methodsSuitable analytical methods shall be chosen for the tests indicated in annex A and for any additional testscontained in the study protocol. The methods selected shall be recorded. If a method is selected that is notincluded among those listed in annex C, the method and the details of its validation, demonstrating the capability ofthe method, shall also be documented.4.3 Product stability studies4.3.1 Real-time shelf-life and package integrity studyAnnex A lists tests that shall be performed depending on intraocular lens type.For new intraocular lens types, additional parameters shall be considered for testing, depending upon the nature ofthe intraocular lens. In the case where a specific test listed in annex A has not been carried out, the reasons forthat shall be stated.Testing for changes due to interaction with the packaging material shall be considered, as shall testing for changesin the concentration of additives and coatings in addition to those listed in annex A.For one of the finished intraocular lens lots, the tests chosen shall be carried out initially and at intervals inaccordance with the protocol up to and including the manufacturers desired expiration date (maximum five years).The other finished intraocular lens lots shall be tested, at least initially and at the desired expiration date.The following is the procedure for real-time stability studies. Intraocular lenses to be tested shall, if applicable, ateach instance be evenly distributed among the different power groups (see annex A).¾ Assign a unique identification to each individual intraocular lens in the total sample and put that identificationon the intraocular lens packaging.¾ Collect the intraocular lenses to be tested initially and carry out the tests of the protocol. Record the uniqueidentifications, the results and measurement conditions.¾ Transfer the remaining packages to storage under controlled conditions (25 °C ± 3 °C at 60 % ± 20 % relativehumidity). Record actual temperature, relative humidity and date.¾ Monitor temperature and relative humidity regularly during the course of the study in a manner that fluctuationsin temperature and relative humidity are also recorded.¾ In accordance with the protocol, periodically remove a sufficient number of intraocular lenses for testing. Allowthe intraocular lenses to equilibrate, within the original packaging, to the initial measurement conditions. Thencarry out the tests of the protocol. Record the unique identifications, the results and measurement conditions.SIST EN 13503-6:2003



EN 13503-6:2002 (E)6¾ Collect the intraocular lenses to be tested at the expiration date. Allow the intraocular lenses to equilibrate,within the original packaging, to the initial measurement conditions. Then carry out the tests of the protocol.Record the unique identifications, the results and measurement conditions.The parameters measured shall remain within the specified limits of the applicable parts of EN ISO 11979 orEN 13503. In the case where there are no limits specified in EN ISO 11979 or EN 13503, the parameters measuredshall remain within the manufacturer's internal finished product release specifications. If, during the course of thestudy, a parameter is no longer found to conform to the specifications at two or more consecutive time intervals, themaximum shelf-life of the intraocular lens under study has been reached at the last conforming measurement point.4.3.2 Accelerated shelf-life studyStudies under accelerated conditions are likely to speed up any degradation processes, and ma
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