AAMI ISO 13485:2003 (R2009)被替代
Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes
出版：Association for Advancement of Medical Instrumentation
專家解讀視頻
基本信息
標準編號： AAMI ISO 13485:2003 (R2009)
發布時間：2009/11/9 0:00:00
標準類別：Standard
出版單位：Association for Advancement of Medical Instrumentation
標準頁數：64
標準簡介
Describes 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 requirements and regulatory requirements applicable to medical devices and related services.
標準備注
Supersedes AAMI ISO 13488 (06/2004)
本標準替代的舊標準
替代本標準的新標準
