DIN EN ISO 13485 (2003-11)废止
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
出版：German Institute for Standardisation (Deutsches Institut für Normung)
专家解读视频
基本信息
标准编号： DIN EN ISO 13485 (2003-11)
发布时间：2003/11/1 0:00:00
标准类别：Standard
出版单位：German Institute for Standardisation (Deutsches Institut für Normung)
标准页数：73
标准简介
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.
标准备注
Supersedes DIN EN 46001 E
(11/2001)
Supersedes DIN EN ISO 13488 E
(02/2004)
Suspended until publication of a revised English text, due to a
new German edition.
(10/2007)
等同采用的国际标准
ISO 13485:2003 - Identical
