Category: AAMI

Sterilization of health care products – Radiation – Guidance on dose setting utilizing a Modified Method 2
standard by Association for the Advancement of Medical Instrumentation, 01/31/2018

Electrical Safety Manual, 2008 Edition
Handbook / Manual / Guide by Association for the Advancement of Medical Instrumentation, 01/01/2008

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
standard by Association for the Advancement of Medical Instrumentation, 09/03/2009

AAMI Standards and Recommended Practices – Part 1:Sterilization in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 09/01/2000

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

Validation of software for regulated processes
standard by Association for the Advancement of Medical Instrumentation, 12/13/2007

AAMI Standards and Recommended Practices – Sterilization, Part 2: Sterilization Equipment, 2013 Edition
standard by Association for the Advancement of Medical Instrumentation, 2013

Sterilization Pt 1: Sterilization in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 2013

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

Guidance for the use of medical equipment maintenance strategies and procedures
standard by Association for the Advancement of Medical Instrumentation, 02/06/2015