Category: AAMI

Comprehensive guide to steam sterilization and sterility assurance in health care facilities (Consolidated text )
standard by Association for the Advancement of Medical Instrumentation, 08/23/2012

Leukocyte reduction filters
standard by Association for the Advancement of Medical Instrumentation, 11/29/2012

Standard for Safety for Medical Device Interoperability (ANSI/AAMI/UL 2800-1:2019)
standard by Association for the Advancement of Medical Instrumentation, 02/25/2019

Active implantable medical devices – Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
standard by Association for the Advancement of Medical Instrumentation, 11/30/2011

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

Comprehensive guide to steam sterilization and sterility assurance in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 09/04/2010

Chemical sterilization and high-level disinfection in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 12/06/2005

AAMI Standards and Recommended Practices – Volume 4: Biological Evaluation of Medical Devices
standard by Association for the Advancement of Medical Instrumentation, 04/01/1997

Compatibility of materials subject to sterilization
standard by Association for the Advancement of Medical Instrumentation, 06/11/2017

U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
standard by Association for the Advancement of Medical Instrumentation, 08/30/2019