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
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor. 1:2009); German version EN ISO 13485:2003 + AC:2009
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 devices. Different from DIN EN ISO 13485:2001-02 and DIN EN ISO 13488:2001-02, the revised standard DIN ISO 13485 is a stand-alone standard. Organisations whose quality management systems conform to DIN ISO 13485 cannot claim conformity to ISO 9001:2000 unless their quality