UNI CEI EN ISO 13485:2012被替代
Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes
出版：Italian Standards
专家解读视频
Defines requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.
Supersedes UNI CEI EN 46001. (06/2002)
CEI UNI EN ISO 13485 Ed. 5 (2012) - Identical
CEI UNI EN ISO 13485 : 2012 - Identical
ISO 13485 : 2016 - Identical
EN ISO 13485 : 2016 COR 2018 - Identical
