
QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9003
出版:European Committee for Standards - Electrical

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基本信息
標準編號: EN 46003 : 1999
標準類別:Standard
出版單位:European Committee for Standards - Electrical
標準頁數:0
標準簡介
Defines, in conjunction with EN ISO 9003:1994, the quality system requirements for the final inspection and test of medical devices excluding in vitro diagnostic medical devices and active implantable medical devices, and is applicable when a medical device supplier's quality system is assessed in accordance with regulatory requirements.