Historical
ANSI/AAMI/ISO 14155-1:2003
Clinical Investigation Of Medical Devices for Human Subjects - Part 1: General Requirements
Defines procedures for the conduct and performance of clinical investigations of medical devices. This standard was listed for public review in the 12/3/1999 issue of Standards Action. It is being resubmitted due to substantive changes to the text.
Association for the Advancement of Medical Instrumentation [aami]