AAMI ISO 13485 Ed. 2 (2003)现行
Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes
出版：Association for Advancement of Medical Instrumentation
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基本信息
标准编号： AAMI ISO 13485 Ed. 2 (2003)
发布时间：2003/6/6 0:00:00
标准类别：Standard
出版单位：Association for Advancement of Medical Instrumentation
标准页数：64
标准简介
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.
标准备注
Supersedes AAMI ISO 13488 (06/2004)
本标准替代的旧标准
等同采用的国际标准
ISO 13485:2003 - Identical
