DS EN ISO 13485:2012被替代
Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes
出版：Danish Standards
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基本信息
标准编号： DS EN ISO 13485:2012
发布时间：2012/3/9 0:00:00
标准类别：Standard
出版单位：Danish Standards
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.
替代本标准的新标准
等同采用的国际标准
EN ISO 13485:2016 - Identical
