Category: AAMI

Medical device safety assurance case report guidance
standard by Association for the Advancement of Medical Instrumentation, 01/25/2019

Periodic review of ANSI/AAMI ST40:2004, Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities (Reaffirmed 2010)
standard by Association for the Advancement of Medical Instrumentation, 10/07/2004

Blood transfusion micro-filters
standard by Association for the Advancement of Medical Instrumentation, 08/24/2007

Product adoption and process equivalency for ethylene oxide sterilization
standard by Association for the Advancement of Medical Instrumentation, 11/18/2016

Biological Evaluation of Medical Devices, Supplement 2 (1999)
standard by Association for the Advancement of Medical Instrumentation, 02/28/1999

Disposable ECG electrodes
standard by Association for the Advancement of Medical Instrumentation, 01/06/2005

Human factors engineering – Design of medical devices
standard by Association for the Advancement of Medical Instrumentation, 10/21/2009

Bacterial endotoxins – Test methodologies, routine monitoring, and alternatives to batch testing
standard by Association for the Advancement of Medical Instrumentation, 09/01/2002

Selection and use of protective apparel and surgical drapes in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 02/05/2006

Automatic, External Defibrillators and Remote Control Defibrillators
standard by Association for the Advancement of Medical Instrumentation, 09/01/1993

A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
standard by Association for the Advancement of Medical Instrumentation, 08/10/2011

Processing of health care products – Quality management systems for processing in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 07/18/2017