BS ENIS0 22442-2:2020 BSl Standards Publication Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling bsi. BSENISO22442-2:2020 BRITISH STANDARD National foreword This British Standard is the UK implementation of ENIS022442-2:2020.It is identicaltoIS022442-2:2020.Itsupersedes BS EN IS0 22442-2:2015, which is withdrawn. TheUKparticipationinitspreparationwas entrustedtoTechnical Committee CH/194,Biological evaluation ofmedical devices. 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. @TheBritish Standards Institution 2020 Published by BSI Standards Limited 2020 ISBN9780539016703 ICS11.020.20;11.100.20;11.100.99 Compliancewith aBritish Standard cannotconferimmunity from legalobligations. This British Standard was published under the authority of the StandardsPolicyandStrategyCommitteeon31December2020 Amendments/corrigendaissuedsincepublication Date Text affected EUROPEANSTANDARD EN ISO 22442-2 NORME EUROPEENNE EUROPAISCHE NORM December 2020 ICS11.100.20 SupersedesENIS022442-2:2015 English Version Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (IS0 22442-2:2020) Dispositifs medicaux utilisant des tissus animaux Tierische Gewebe und deren Derivate, die et leurs derives - Partie 2: Controles de I'origine, de zur Herstellung von Medizinprodukten la collecte et du traitement (IS0 22442-2:2020) eingesetzt werden - Teil 2: Kontrollen der Beschaffung, Materialgewinnung und Handhabung (IS0 22442-2:2020) This European Standard was approved by CEN on2December 2020 CEN members are bound to complywith the CEN/CENELEC Internal Regulations which stipulate theconditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical 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 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 COMITE EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEEFURNORMUNG 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 22442-2:2020: E worldwide for CEN national Members