BSENIS011138-8:2021 BSl Standards Publication Sterilization of health care products - Biological indicators Part 8: Method for validation of a reduced incubation time for a biological indicator bsi. BSENISO11138-8:2021 BRITISH STANDARD National foreword This British Standard is theUK implementation of EN IS0 11138-8:2021 It is identical toIS011138-8:2021. TheUKparticipation inits preparation was entrustedto Technical Committee CH/198, Sterilization and Associated Equipment and Processes. A list of organizations represented on this committee can be obtained on request to its committee manager. Contractualandlegalconsiderations This publication hasbeen prepared in good faith, however no representation,warranty,assurance or undertaking (expressor implied) is or will be made, and no responsibility or liability is or will be reasonableness of this publication.All and any such responsibility and liability is expresslydisclaimed to the full extent permitted by thelaw. This publication is provided as is,and isto beused at the recipient's own risk. The recipient is advised to consider seeking professional guidance with respecttoitsuseofthispublication. This publication is not intended to constitute a contract. Users are responsibleforitscorrectapplication. TheBritishStandards Institution2021 PublishedbyBSIStandardsLimited2021 ISBN9780580915819 ICS11.080.01 Compliance with a British Standard cannot confer immunityfrom legal obligations. This British Standard was published under the authority of the StandardsPolicyand Strategy Committeeon31 July2021. Amendments/corrigendaissuedsincepublication Date Textaffected EUROPEANSTANDARD ENIS0 11138-8 NORMEEUROPEENNE EUROPAISCHE NORM July 2021 ICS11.080.01 English Version Sterilization of health care products - Biological indicators-Part8:Methodforvalidationofareduced incubation timefor a biologicalindicator(Iso 11138-8:2021) Sterilisation des produits de sante- Indicateurs Sterilisation von Produkten fur die biologiques - Partie 8: Méthode pour la Gesundheitsfursorge-Biologische validation d'un temps d'incubation reduit pour Indikatoren - Teil 8: Methode zur Validierung un indicateur biologique (IS0 11138-8:2021) einerreduzierten Inkubationszeiteines biologischen Indikators (IS0 11138-8:2021) This European Standard was approved by CEN on 24 June 2021. this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards maybe obtained on application to the CEN-CENELEC Management Centre orto any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made bytranslation under the responsibility ofa CEN member into its own language and notified to the CEN-CENELEC Management Centrehasthesamestatusastheofficialversions. 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 COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEEFURNORMUNG CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels 2021CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-8:2021: E worldwide for CEN national Members