DIN EN ISO 13485 (2003-11)廢止
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003)
出版：German Institute for Standardisation (Deutsches Institut für Normung)
專家解讀視頻
基本信息
標準編號： DIN EN ISO 13485 (2003-11)
發布時間：2003/11/1 0:00:00
標準類別：Standard
出版單位：German Institute for Standardisation (Deutsches Institut für Normung)
標準頁數：73
標準簡介
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.
標準備注
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)
等同采用的國際標準
ISO 13485:2003 - Identical
