标准号:DIN-Fachbericht CEN ISO/TR 14969-2005
中文标准名称:医疗器件.质量管理系统.ISO 13485-2003应用指南
英文标准名称:Medical devices - Quality management systems - Guidance on the application of ISO 13485:2003 (ISO/TR 14969:2004); German version CEN ISO/TR 14969:2005
标准类型:C30
发布日期:1999/12/31 12:00:00
实施日期:1999/12/31 12:00:00
中国标准分类号:C30
国际标准分类号:03.120.10;11.040.01
适用范围: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.#,,#