AAMI 14971 1:1999被替代
Medical Devices - Risk Management - Part 1: Application Of Risk Analysis
出版：Association for Advancement of Medical Instrumentation
专家解读视频
Defines a method for the investigation, using available information, of the safety of a medical device, including in vitro diagnostic devices (IVD) or accessories, by identifying hazards and estimating the risks associated with the device. Possibly of particular assistance in areas where relevant standards are not available or are not used.
ISO 14971-1:1998 - Identical
ISO 14971-1 : 1998 - Identical
ISO 14971-1 : 1998 - Identical
