I.S. EN ISO 13485:2016&LC:2016&AC:2018被替代
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
出版：National Standards Authority of Ireland
专家解读视频
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
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/AC:2018 - Identical
