ISO/DIS 13485 (2003)被替代
Quality Systems - Medical Devices - System Requirements For Regulatory Purposes
出版：International Organization for Standardization
專家解讀視頻
基本信息
標準編號： ISO/DIS 13485 (2003)
標準類別：Draft
出版單位：International Organization for Standardization
標準頁數：0
標準簡介
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.
替代本標準的新標準
等同采用的國際標準
DIN ISO 13485 (2002-05) - Identical
