Category: AAMI

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

Sterilization, Part 3: Industrial Process Control, 2013 Edition
standard by Association for the Advancement of Medical Instrumentation, 2013

Generating reports for human factors design validation results for external cardiac defibrillators
standard by Association for the Advancement of Medical Instrumentation, 10/24/2014

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

Hospital steam sterilizers
standard by Association for the Advancement of Medical Instrumentation, 12/04/2008

Medical Equipment Management Manual, 2004
Handbook / Manual / Guide by Association for the Advancement of Medical Instrumentation, 01/01/2004

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

Hemodialyzers
standard by Association for the Advancement of Medical Instrumentation, 03/08/1996

Systems Used to Forecast Remaining Pacemaker Battery Service Life
standard by Association for the Advancement of Medical Instrumentation, 12/01/1998

Comprehensive guide to steam sterilization and sterility assurance in health care facilities, Amendment 3
Amendment 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

Reprocessing of Hemodialyzers
standard by Association for the Advancement of Medical Instrumentation, 05/08/2008