BS ENIS0 22442-1:2020 BSl Standards Publication Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management bsi. BSENISO22442-1:2020 BRITISH STANDARD Nationalforeword This British Standard is theUK implementation of ENIS022442-1:2020. Itis identical toIS022442-1:2020.ItsupersedesBSENIS022442-1:2015 which is withdrawn. TheUKparticipationinitspreparationwas entrustedtoTechnical Committee CH/194,Biological evaluation ofmedical devices. Alistof organizationsrepresentedonthis committeecanbeobtained on requestto 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 ISBN9780539004588 ICS11.020.20;11.100.20 Compliancewith aBritish Standard cannot confer immunityfrom legalobligations. This British Standard was published under the authority of the StandardsPolicyandStrategyCommitteeon31December2020. Amendments/corrigendaissuedsincepublication Date Textaffected BSENISO22442-1:2020 EN ISO 22442-1 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHE NORM December 2020 ICS11.100.20 Supersedes ENIS022442-1:2015 EnglishVersion Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (IsO 22442-1:2020) Dispositifs medicaux utilisant des tissus animaux et Tierische Gewebe und deren Derivate, die zur leurs derives - Partie 1: Application de la gestion des Herstellung von Medizinprodukten eingesetzt werden - risques (Is0 22442-1:2020) Teil 1: Anwendung des Risikomanagements (ISO 22442-1:2020) This European Standard was approved by CEN on 2 December 2020. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for givingthis 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 COMITE EUROPEENDENORMALISATION EUROPAISCHESKOMITEEFURNORMUNG 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 IS0 22442-1:2020 E worldwideforCENnationalMembers