SIS-EN-ISO-13485 › Complete Document History
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)

Complete Current Edition:
   EDITION 4 - ENGLISH LANGUAGE EDITION - March 7, 2016
   2016/AC:2017 EDITION CORRIGENDUM - CORRIGENDUM 1 FOR 2016 EDITION - March 23, 2016
   2016/AC:2018 EDITION CORRIGENDUM - CORRIGENDUM 2 FOR 2016 EDITION - Jan. 18, 2018
   2016/A11 2021 EDITION - AMENDMENT 11 FOR 2016 EDITION - Sept. 13, 2021

Obsolete Revision Information:
   ED. 3 CORRIGENDUM 1 - CORRIGENDUM 1 FOR 2012 EDITION - Oct. 16, 2012
   EDITION 3 - ENGLISH LANGUAGE EDITION - March 6, 2012
   ED 2 CORRIGENDUM 2 - CORRIGENDUM 2 FOR EDITION 2 - Sept. 15, 2009
   ED. 2 CORRIGENDUM 1 - CORRIGENDUM 1 FOR EDITION 2 - Sept. 7, 2007
   EDITION 2 - ENGLISH LANGUAGE EDITION - Aug. 15, 2003