EN 13503-6:2002

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
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

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

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
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