Category: AAMI

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

Table-Top Steam Sterilizers
standard by Association for the Advancement of Medical Instrumentation, 11/01/2016

Principles for medical device security – Risk management
standard by Association for the Advancement of Medical Instrumentation, 06/05/2016

Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
standard by Association for the Advancement of Medical Instrumentation, 02/09/2006

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, 01/01/2013

Processing of reusable surgical textiles for use in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 03/04/2009

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

Electrical Safety Manual, 2008 Edition
Handbook / Manual / Guide by Association for the Advancement of Medical Instrumentation, 01/01/2008

Guidance on selecting a microbial challenge and inoculation sites for sterilization validation of medical devices
standard by Association for the Advancement of Medical Instrumentation, 09/03/2009