PD IS0/TS 19930:2017 BSl Standards Publication Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 bsi. PDIS0/TS19930:2017 PUBLISHEDDOCUMENT Nationalforeword This Published Document is the UK implementation of ISO/TS19930:2017. The UK participation in its preparation was 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 ofa contract.Users areresponsiblefor its correctapplication. TheBritishStandardsInstitution2017 Published by BSI Standards Limited 2017 ISBN9780580951619 ICS 11.080.01 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Standards Policy and Strategy Committee on30November2017. Amendments/corrigendaissuedsincepublication Date Textaffected PDIS0/TS19930:2017 TECHNICAL ISO/TS 19930 SPECIFICATION First edition 2017-12-30 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 Document d'orientation sur les aspects d'uneapproche, fondee sur I'appreciation du risque,permettant d'assurer la sterilite des produits de sante d usageunique, soumis d une sterilisation terminaley compris ceuxnepouvantpas supporteruntraitementatteignantun niveaud'assurancedelasterilitemaximal de10-6 Reference number ISO/TS19930:2017(E) ISO @ISO2017