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NS EN ISO 13485:2012现行

Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes (Iso 13485:2003+Cor 1:2009)

出版：Norwegian Standards (Norges Standardiseringsforbund)

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基本信息

标准编号： NS EN ISO 13485:2012

发布时间：2012/5/1 0:00:00

标准类别：Standard

出版单位：Norwegian Standards (Norges Standardiseringsforbund)

标准页数：104

标准简介

Defines 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 ISO 13485:2003

等同采用的国际标准

BS EN ISO 13485:2012 - Identical

NEN EN ISO 13485:2012 - Identical

SS EN ISO 13485 Ed. 3 (2012) - Identical

UNE EN ISO 13485:2012 - Identical

DIN EN ISO 13485 (2012-11) - Identical

ONORM EN ISO 13485:2012 - Identical

DIN EN ISO 13485 (2010-01) - Identical