PN EN ISO 13485:2016现行
Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes (Iso 13485:2016)
出版：Polish Committee for Standardization
专家解读视频
2016 [22/04/2016]2012 AC 2013 [31/03/2013]2012 [20/04/2012]2005 AC 2009 [02/11/2009]2005 AC 2007 [31/08/2007]2005 [16/11/2005]2004 [15/02/2004]2002 [06/12/2002]
Supersedes PN EN 46003. (09/2007)
EN ISO 13485:2016 - Identical
EN ISO 13485 : 2016 COR 2018 - Identical
ISO 13485 : 2016 - Identical
EN ISO 13485 : 2016 COR 2018 - Identical
ISO 13485 : 2016 - Identical
EN ISO 13485:2016 - Identical
