The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the …

This document supersedes EN ISO 14971:2012. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to …

ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for …

20年来， ISO/EN ISO 14971 一直是医疗器械风险管理的国际标准。 如果国内医疗器械制造商计划将产品销往美国或欧盟甚至其他国家或地区，满足该标准是该企业获得 FDA 、 MDR 、 IVDR …

It is explained that the process described in ISO 14971 can be used for managing risks associated with medical devices, including those related to data and systems security. The …

new edition of BS EN ISO 14971 with identical technical content as BS EN ISO 14971:2019 and a national foreword. The guidance report is adopted in the United Kingdom as PD CEN ISO/TR …

This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC 62A, Common aspects of …

2019年12月1日 · The process described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and …