DIN EN ISO 13485:2012 医疗器械.质量管理体系.调整要求(ISO 13485-2003 + Cor. 1-2009).德文版本EN ISO 13485-2012 + AC-2012
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2012 + AC:2012