BS ENIS0 14155:2020 Incorporating corrigendum November 2020 BSl Standards Publication Clinical investigation of medical devices for human subjects Good clinical practice bsi. BSENISO14155:2020 BRITISH STANDARD National foreword This British Standard is theUK implementation of ENIS014155:2020 It is identical toIS014155:2020.It supersedes BSENIS014155:2011, which is withdrawn. TheUK participation inits preparationwas entrusted to Technical Committee CH/194,Biological evaluation ofmedical devices. A list oforganizations represented on this committee can be obtained on request to its committee manager This publication does not purport to include all the necessary provisions ofa contract.Users are responsiblefor its correct application. @TheBritishStandards Institution2020 Published by BSI Standards Limited 2020 ISBN9780539162202 ICS 11.100.20 Compliance with a British Standard cannot confer immunityfrom legal obligations. This British Standard was published under the authority of the StandardsPolicyandStrategyCommitteeon31August2020. Amendments/corrigendaissuedsincepublication Date Textaffected 30November2020 ImplementationofCENcorrectionnotice19Au- gust 2020:correction of yearto2019 in table in Europeanforeword EN ISO 14155 EUROPEANSTANDARD NORME EUROPEENNE EUROPAISCHE NORM August 2020 ICS11.100.20 Supersedes ENIS0 14155:2011 English Version Clinical investigation ofmedical devicesforhuman subjects- Go0d clinicalpractice (IS0 14155:2020) Investigation clinique des dispositifs Klinische Prifung von Medizinprodukten an medicauxpour sujetshumains-Bonne Menschen -Gute klinische Praxis (IS0 14155:2020) pratique clinique (IS0 14155:2020) 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, 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 14155:2020: E worldwide for CEN national Members