Category: AAMI

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

Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 06/21/2012

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

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

Dry Heat (Heated Air) Sterilizers
standard by Association for the Advancement of Medical Instrumentation, 04/07/2004

ANSI/AAMI ES60601-1:2005, Medical electrical equipment – Part 1: General requirements forbasic safety and essential performance, Amendment 1 (2012
Amendment by Association for the Advancement of Medical Instrumentation, 02/09/2006