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I.S. EN 46003:2000被替代

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

出版：National Standards Authority of Ireland

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基本信息

标准编号： I.S. EN 46003:2000

标准类别：Standard

出版单位：National Standards Authority of Ireland

标准页数：12

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.

替代本标准的新标准

I.S. EN ISO 13485:2003

I.S. EN ISO 13485:2016

等同采用的国际标准

NEN EN 46003:1999 - Identical

SS EN 46003 Ed. 1 (2000) - Identical

UNE EN 46003:2000 - Identical

NS EN 46003 Ed. 1 (1999) - Identical

NF EN 46003:1999 - Identical

NBN EN 46003 Ed. 1 (2000) - Identical

DIN EN 46003 (1999-10) - Identical

BS EN 46003:1999 - Identical