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NS EN ISO 13485:2003被替代

Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes

出版：Norwegian Standards (Norges Standardiseringsforbund)

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基本信息

标准编号： NS EN ISO 13485:2003

发布时间：2003/8/11 0:00:00

标准类别：Standard

出版单位：Norwegian Standards (Norges Standardiseringsforbund)

标准页数：100

标准简介

Describes the 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 applicable to medical devices and related services.

标准备注

Supersedes NS EN ISO 13488 (08/2003) Supersedes NS EN 46003. (12/2007)

本标准替代的旧标准

NS EN 46003 Ed. 1 (1999)

NS EN ISO 13488 Ed. 1 (2001)

替代本标准的新标准

NS EN ISO 13485:2012

等同采用的国际标准

ONORM EN ISO 13485:2010 - Identical

SN EN ISO 13485:2003 - Identical

BS EN ISO 13485:2003 - Identical

DIN EN ISO 13485 (2007-10) - Identical