AAMI 14971 1 : 1999
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
MEDICAL DEVICES - RISK MANAGEMENT - PART 1: APPLICATION OF RISK ANALYSIS
07-27-2013
01-12-2013
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.
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