EUROPEAN STANDARD EN ISO 14971 NORME EUROPEENNE EUROPAISCHE NORM December 2019 ICS11.040.01 Supersedes EN ISO 14971 :2012 English version Medical devices - Applicationof risk management to medical devices ( 14971 :2019 ) Dispositifs medicaux -Application de la gestion des Medizinprodukte -Anwendung des risques aux dispositifs medicaux ( 14971 :2019 ) Risikomanagements auf Medizinprodukte ( ISO 14971:2019 This European Standard was approved by CEN on 5 August 2019 . CEN and CENELEC members are bound to ply with the CEN /CENELECInternal 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 and CENELEC member . 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 and CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions . CEN and CENE...
EN ISO 14974-2019 Medical devices - Application of risk management tomedical devices （ISO 14971：2019）.pdf
