Category: AAMI
AAMI
AAMI TIR61:2014/(R)2019
Generating reports for human factors design validation results for external cardiac defibrillators
standard by Association for the Advancement of Medical Instrumentation, 10/24/2014
AAMI TIR 27
Sterilization of health care products – Radiation sterilization – Substantiation of 25 kGy as a sterilization dose – Method VD max
standard by Association for the Advancement of Medical Instrumentation, 10/09/2001
AAMI ST91:2015
Flexible and semi-rigid endoscope processing in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 04/10/2015
AAMI HA60601-1-11:2015 (IEC 60601-1-11:2015, MOD)
Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015, MOD)
standard by Association for the Advancement of Medical Instrumentation, 08/25/2015
AAMI ST8:2008
Hospital steam sterilizers
standard by Association for the Advancement of Medical Instrumentation, 12/04/2008
AAMI TIR102:2019
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
AAMI RD16-96
Hemodialyzers
standard by Association for the Advancement of Medical Instrumentation, 03/08/1996
AAMI BF64:2012
Leukocyte reduction filters
standard by Association for the Advancement of Medical Instrumentation, 11/29/2012
AAMI RD47:2008/(R)2013
Reprocessing of Hemodialyzers
standard by Association for the Advancement of Medical Instrumentation, 05/08/2008
AAMI BEBK5-2
AAMI Standards and Recommended Practices – Volume 2.2 – Biomedical Equipment, Part 2: Monitoring and Diagnostic Equipment
standard by Association for the Advancement of Medical Instrumentation, 12/01/1995
AAMI ST58-96
Safe Use and Handling of Glutaraldehyde-Based Products in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 08/01/1996