IEC 60601-1-11, 1st edition, just published Apr 28, 2010. This is the Medical electrical equipment collateral Standard for Medical electrical equipment & systems used in home healthcare environments.
FDA establishes a Home Use Medical Devices Web Page
FDA establishes a Home Use Devices Web PAge – Repository of Info on FDA perspective for Home Use Med Dvcs http://ow.ly/1El0q
FDA Workshop on Med Dvc Use in Home Environ – May 24, ’10
FDA Workshop on Med Dvc Use in Home Environ: Implications of Med Dvc Technology Migrating Into Home Use, May 24, 2010 http://ow.ly/1EjTN
Draft FDA Guidance – Infusion Pumps – Total Product Life Cycle – Premarket Notification [510(k)] Submissions
Draft FDA Guidance – Infusion Pumps – Total Product Life Cycle – Premarket Notification [510(k)] Submissions http://ow.ly/1EjNL
STERIS System 1 (SS1) Resource AAMI web pg
STERIS System 1 (SS1) Resource AAMI web pg http://ow.ly/1EjJE links to background, FDA, STERIS, assess alternatives, Endoscope Reprocessing
