Category: AAMI

Leukocyte reduction filters
standard by Association for the Advancement of Medical Instrumentation, 06/11/2003

Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
standard by Association for the Advancement of Medical Instrumentation, 07/29/2019

Guidance for the development, validation and routine control of an ethylene oxide sterilization process utilizing flexible bag systems for the sterilization of medical devices
standard by Association for the Advancement of Medical Instrumentation, 12/27/2013

Book by Association for the Advancement of Medical Instrumentation, 2014

Medical device software – Software life cycle processes
standard by Association for the Advancement of Medical Instrumentation, 06/05/2001

Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 4
Amendment by Association for the Advancement of Medical Instrumentation, 10/14/2013

Parametric release for ethylene oxide sterilization
standard by Association for the Advancement of Medical Instrumentation, 09/24/2001

Recommended practices for a medical equipment management program
standard by Association for the Advancement of Medical Instrumentation, 12/17/2008

Radiation Sterilization-Material Qualification
standard by Association for the Advancement of Medical Instrumentation, 10/01/1998

ECG Cables and Wires
standard by Association for the Advancement of Medical Instrumentation, 12/04/2008

Cardiac Monitors, Heart Rate Meters, and Alarms (Includes February 2008 Corrections)
standard by Association for the Advancement of Medical Instrumentation, 11/01/2002

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