BSENIS013408-2:2018 Bsl Standards Publication Aseptic processing of health care products Part 2: Sterilizing filtration bsi. BSENIS013408-2:2018 BRITISH STANDARD National foreword This British Standard is theUK implementation of ENIS013408-2:2018.It is identicaltoIS013408-2:2018.It supersedes BS ENIS0 13408-2:2011, which is withdrawn. TheUK participationinitspreparationwas entrusted to Technical Committee CH/198,Sterilization and Associated Equipment and Processes. A list of organizations represented on this committee can be obtained on requestto its secretary. This publication does not purport to include all the necessary provisions ofacontract.Usersareresponsibleforits correct application. The British Standards Institution 2018 Published byBSI Standards Limited 2018 ISBN9780580868665 ICS 11.080.01 Compliance with a British Standard cannot confer immunityfrom legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30April2018. Amendments/corrigendaissuedsincepublication Date Text affected EUROPEANSTANDARD ENIS0 13408-2 NORME EUROPEENNE EUROPAISCHE NORM March 2018 ICS11.080.01 Supersedes ENIS013408-2:2011 English Version Aseptic processing of health care products - Part 2: Sterilizing filtration (1s0 13408-2:2018) Traitement aseptique des produits de santé- Partie Aseptische Herstellung von Produkten 2:Filtration sterilisante (IS013408-2:2018) fur die Gesundheitsfuirsorge - Teil 2: Sterilfiltration (IS0 13408-2:2018) This European Standard was approved by CEN on 2 January 2018. 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 Management Centre has the same status asthe 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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. cen EUROPEAN COMMITTEE FOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHESKOMITEEFURNORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17,B-1000 Brussels 2018CEN All rights of exploitation in any form and by any means reserved Ref. No. EN IS0 13408-2:2018: E worldwide for CEN national Members