DIN EN ISO 13485-2010 医疗装置.质量管理体系.调整要求(ISO 13485-2003 + Cor. 1-2009).德文版本EN ISO 13485-2003 + AC-2009
DIN EN ISO 13485-2010 标准详情
- 标准号:DIN EN ISO 13485-2010
- 中文标题:医疗装置.质量管理体系.调整要求(ISO 13485-2003 + Cor. 1-2009).德文版本EN ISO 13485-2003 + AC-2009
- 英文标题:Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009
- 标准类别:德国标准
- 发布日期:2010-01
内容简介
This standard specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices that consistently meet customer requirements and regulatory requirements applicable to medical devi
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