AAMI ISO 10993-1 : 2009 : INC : ERR 1 : 2013已作廢
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS
出版：Association for the Advancement of Medical Instrumentation
專家解讀視頻
Specifies: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on the nature and duration of their contact with the body; - the evaluation of existing relevant data from all sources; - the identification of gaps in the available data set on the basis of a risk analysis; - the identification of additional data sets necessary to analyze the biological safety of the medical device; - the assessment of the biological safety of the medical device.
ISO 10993-1 : 2009 - Identical
