Category: AAMI

Evaluation of particulates associated with vascular medical devices
standard by Association for the Advancement of Medical Instrumentation, 12/13/2010

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

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

Technical Information Report Sorbent-based regenerative hemodialysis systems
standard by Association for the Advancement of Medical Instrumentation, 06/08/2018

Medical electrical equipment-Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD), Consolidated Text of ES60601-1:2005/(R)2012 and A1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
standard by Association for the Advancement of Medical Instrumentation, 02/09/2006