NEW Standards Committee Central
BE - WG 04 - Clinical Investigations Working Group
AAMI Staff Contact
The AAMI BE/WG 04 - Clinical Investigations Working Group provides input into international standards developed by ISO/TC 194/WG 4 - Clinical investigations of medical devices in humans, through the AAMI BE Committee which is the mirror committee and U.S. TAG to ISO/TC 194.
- ANSI/AAMI/ISO 14155:2011, Clinical investigation of medical devices for human subjects -- Good clinical practice