Category: AAMI

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

Flexible and semi-rigid endoscope processing in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 04/10/2015

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

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

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

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

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