BS ENIS0 5840-1:2021 BSl Standards Publication Cardiovascular implants Cardiac valve prostheses Part 1: General requirements bsi. BSENIS05840-1:2021 BRITISH STANDARD National foreword This British Standard is theUK implementation of ENIS05840-1:2021. It is identical to IS0 5840-1:2021.It supersedes BS EN IS0 5840-1:2015, which is withdrawn. The UK participation in its preparation was entrusted to Technical CommitteeCH/150/2,Cardiovascularimplants. request to its committee manager. This publication does not purport to include all the necessary provisions ofa contract.Users areresponsiblefor its correctapplication TheBritish Standards Institution2021 Published by BSI Standards Limited 2021 ISBN9780539027907 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal obligations. This British Standard was published under the authority of the Amendments/corrigendaissuedsincepublication Date Textaffected BSENISO5840-1:2021 EN IS0 5840-1 EUROPEANSTANDARD NORMEEUROPEENNE EUROPAISCHE NORM February 2021 ICS11.040.40 Supersedes ENIS05840-1:2015 English Version Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements (IS0 5840-1:2021) Implants cardiovasculaires - Protheses valvulaires - Herz- und Gefafsimplantate - Herzklappenprothesen - Partie 1: Exigences genérales (IS0 5840-1:2021) Teil 1: Allgemeine Anforderungen (IS0 5840-1:2021) ThisEuropeanStandardwasapprovedbyCENon22September2020 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 standardsmay be obtained on application tothe 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 EUROPEEN DE NORMALISATION EUROPAISCHES KOMITEE FUR NORMUNG CEN-CENELEC Management Centre:Ruedela Science23, B-1040Brussels @2021CEN All rights of exploitation in any form and by any means reserved Ref.No.EN ISO 5840-1:2021 E worldwide for CEN national Members.