BS ENIS0 11979-5:2020 BSl Standards Publication Ophthalmic implants Intraocular lenses Part 5: Biocompatibility bsi. BSENIS011979-5:2020 BRITISH STANDARD National foreword This British Standard is the UK implementation of ENIS011979-5:2020.Itis identicaltoIS011979-5:2020.Itsupersedes BS ENIS011979-5:2006, which iswithdrawn. TheUKparticipationinitspreparationwas entrustedtoTechnical Committee CH/172/7,Eye implants. Alistof organizationsrepresentedonthis committeecanbe obtained on request to its committee manager. This publication does not purport to include all the necessary provisions ofa contract. Users are responsible for its correct application. The British Standards Institution 2020 Published by BSI Standards Limited 2020 ISBN9780580519574 ICS11.040.70 Compliancewith a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the StandardsPolicyandStrategyCommitteeon31October2020. Amendments/corrigendaissuedsincepublication Date Text affected BSENISO11979-5:2020 EN IS0 11979-5 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHE NORM October2020 ICS 11.040.70 Supersedes ENIS011979-5:2006 English Version Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (IS0 11979-5:2020) Implants ophtalmiques-Lentilles intraoculaires Ophthalmische Implantate - Intraokularlinsen - Teil 5: Partie 5:Biocompatibilite (ISO 11979-5:2020) Biokompatibilitat (IS011979-5:2020) This European Standard was approved by CEN on 22 September 2020. 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITEEUROPEENDENORMALISATION EUROPAISCHES KOMITEE FUR NORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels @2020CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-5:2020 E worldwideforCENnationalMembers