Sterilization of health care products – Radiation – Guidance on dose setting utilizing a Modified Method 2
standard by Association for the Advancement of Medical Instrumentation, 09/03/2009
AAMI STBK9-1-RC01
AAMI Standards and Recommended Practices – Part 1:Sterilization in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 09/01/2000
AAMI TIR22:2007/A1:2008
Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2:2006, Amendment 1
Amendment by Association for the Advancement of Medical Instrumentation, 11/20/2008
AAMI DF39-93
Automatic, External Defibrillators and Remote Control Defibrillators
standard by Association for the Advancement of Medical Instrumentation, 09/01/1993
AAMI TIR66:2017
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
The Quality System Compendium: CGMP Requirements and Industry Practice, Third Edition
Book by Association for the Advancement of Medical Instrumentation, 03/01/2015
AAMI BIOT9
Biological Evaluation of Medical Devices, Supplement 2 (1999)
standard by Association for the Advancement of Medical Instrumentation, 02/28/1999
AAMI TIR52:2014/(R)2017
Environmental Monitoring For Terminally Sterilized Healthcare Products
standard by Association for the Advancement of Medical Instrumentation, 03/10/2014
AAMI RD52:2004/A3:2009 & A4:2009
ANSI/AAMI RD52:2004, Dialysate for hemodialysis, Amendment 3 – Annex E: Special considerations for acute hemodialysis and Amendment 4–Annex C: Special considerations for home hemodialysis, C.5.C Deionization
Amendment by Association for the Advancement of Medical Instrumentation, 04/24/2009
AAMI STBK13-3
Sterilization, Part 3: Industrial Process Control, 2013 Edition
standard by Association for the Advancement of Medical Instrumentation, 01/01/2013