ISO/DIS 13485 (2003)被替代
Quality Systems - Medical Devices - System Requirements For Regulatory Purposes
出版：International Organization for Standardization
专家解读视频
基本信息
标准编号： ISO/DIS 13485 (2003)
标准类别：Draft
出版单位：International Organization for Standardization
标准页数：0
标准简介
Specifies requirements for a quality management systemwhere an organization need to demonstrate its abilityto provide medical devices that consistently meetcustomer requirements and regulatory requirementsapplicable to medical devices.
替代本标准的新标准
等同采用的国际标准
DIN ISO 13485 (2002-05) - Identical
