JIS Q 13485:2005被替代
Medical devices - Quality management systems - Requirements for regulatory purposes
出版：Japanese Standards Association
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基本信息
标准编号： JIS Q 13485:2005
发布时间：2005/10/1 0:00:00
标准类别：Standard
出版单位：Japanese Standards Association
标准页数：58
标准简介
This 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 requirements and regulatory requirements applicable to medical devices and related services.
等同采用的国际标准
ISO 13485:2003 - Identical
