标准号：EN ISO 13485-2012
实施状态：现行
中文名称：医疗器械.质量管理体系.调整要求
英文名称：Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (Incorporating corrigendum July 2012)
发布日期：2012-02-01
被替代标准：EN ISO 13485-2016
代替标准：EN ISO 13485:2003
起草单位：CEN
标准简介：This International Standard specifies requirements for a quality management system where an organizationneeds to demonstrate its ability to provide medical devices and related services that consistently meetcustomer requirements and regulatory requirements applicable to medical devices and related services.
文件格式：PDF
文件大小：1.85MB
文件页数：86
（以上信息更新时间为：2019-11-28）
EN ISO 13485-2012 医疗器械.质量管理体系.调整要求.pdf
(1.85 MB)
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