BS EN IS0 14607:2018 BSl Standards Publication S日 Licensed copy:University of Exeter, University of Exeter, Version correo Non-active surgical implants - Mammary implants - Particular requirements (Is0 14607:2018) bsi. BS EN IS0 14607:2018 BRITISH STANDARD National foreword This British Standard is the UK implementation of EN IS0 14607:2018. It supersedes BS EN IS0 14607:2009, which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/150, Implants for surgery A list of organizations represented on this committee can be obtained on request to its secretary. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. @ The British Standards Institution 2018 Published by BSI Standards Limited 2018 ISBN 978 0 580 89051 2 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 Standards Policy and Strategy Committee on 31 May 2018. Amendments/corrigenda issued since publication Date Textaffected EUROPEAN STANDARD EN IS0 14607 NORME EUROPEENNE EUROPAISCHE NORM May 2018 ICS11.040.40 Supersedes EN IS0 14607:2009 f Exeter, Version correct as of 25/05/2018 English Version Non-active surgical implants - Mammary implants Particular requirements (IS0 14607:2018) Implants chirurgicaux non actifs - Nichtaktive chirurgische Implantate Implants mammaires - Exigences - Mammaimplantate - Besondere particulieres (IS0 14607:2018) Anforderungen (IS0 14607:2018) This European Standard was approved by CEN on 26 February 2018. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving ortoanyCENmember This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC , University of ManagementCentrehasthesamestatusastheofficialversions. CENmembersarethenationalstandardsbodiesof Austria,Belgium,Bulgaria,Croatia,Cyprus,CzechRepublic,Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. Licensed copy: University of Exeter , cen EUROPEANCOMMITTEEFOR STANDARDIZATION COMITE EUROPEEN DE NORMALISATION EUROPAISCHESKOMITEEFURNORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels @2018CEN All rights of exploitation in any form and by any means reserved Ref. No. EN IS0 14607:2018: E worldwide for CEN national Members