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SS EN 46003 Ed. 1 (2000)现行

Quality Systems - Medical Devices - Particular Requirements For The Application Of En Iso 9003

出版:Standardiserings-Kommissionen I Sverige

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基本信息
标准编号: SS EN 46003 Ed. 1 (2000)
发布时间:2000/2/25 0:00:00
标准类别:Standard
出版单位:Standardiserings-Kommissionen I Sverige
标准页数:10
标准简介

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.

等同采用的国际标准

NEN EN 46003:1999 - Identical

UNE EN 46003:2000 - Identical

NS EN 46003 Ed. 1 (1999) - Identical

I.S. EN 46003:2000 - Identical

NF EN 46003:1999 - Identical

NBN EN 46003 Ed. 1 (2000) - Identical

DIN EN 46003 (1999-10) - Identical

BS EN 46003:1999 - Identical

SN EN 46003:1999 - Identical