Category: AAMI
AAMI
AAMI SW91:2018
Classification of defects in health software
standard by Association for the Advancement of Medical Instrumentation, 11/02/2018
AAMI TIR50:2014/(R)2017
Post-market surveillance of use error management
standard by Association for the Advancement of Medical Instrumentation, 03/10/2014
AAMI ST65-2000
Processing of Reusable Surgical Textiles for Use in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation,
AAMI HE74:2001/(R)2009
Human Factors Design Process for Medical Devices
standard by Association for the Advancement of Medical Instrumentation, 10/01/2001
AAMI TIR12:2004
Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
standard by Association for the Advancement of Medical Instrumentation, 03/28/2005
AAMI TIR31:2003
Technical Information Report: Process Challenge Devices/Test Packs for Use in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 03/14/2003
AAMI MP80601-2-49:2020
Medical electrical equipment – Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
standard by Association for the Advancement of Medical Instrumentation, 03/24/2020
AAMI EQ89:2015
Guidance for the use of medical equipment maintenance strategies and procedures
standard by Association for the Advancement of Medical Instrumentation, 02/06/2015
AAMI TIR23:1999/(R)2019
Signal Averaging
standard by Association for the Advancement of Medical Instrumentation, 07/01/1999
AAMI TIR14:1997/A1:2004
Contract Sterilization for Ethylene Oxide, Includes Amendment 1
standard by Association for the Advancement of Medical Instrumentation, 07/15/2004
AAMI TIR66:2017/(R)2020
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
standard by Association for the Advancement of Medical Instrumentation, 02/28/2017
AAMI TIR48:2015
Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
standard by Association for the Advancement of Medical Instrumentation, 08/14/2015