標準號：DIN-Fachbericht CEN ISO/TR 14969-2005
中文標準名稱：醫(yī)療器件.質量管理系統(tǒng).ISO 13485-2003應用指南
英文標準名稱：Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004); German version CEN ISO/TR 14969:2005
標準類型：C30
發(fā)布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C30
國際標準分類號：03.120.10;11.040.01
適用范圍：This technical report provides guidance to assist in the development, implementation and maintenance of quality management systems that aim to meet the requirements of ISO 13485 for organizations that design and develop, produce, install and service medical devices, or that design, develop and provide related service. It provides guidance related to quality management systems for a wide variety of medical devices and related services.#,,#