Sterilization of Health Care Products: Requirements for Validation and Routine Control, Radiation Sterilization
standard by Association for the Advancement of Medical Instrumentation, 07/01/1994

Change summary for ISO 11135:2014, Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
standard by Association for the Advancement of Medical Instrumentation, 08/09/2016

Ethylene Oxide Sterilization Equipment, Process Considerations, and Pertinent Calculations
standard by Association for the Advancement of Medical Instrumentation, 07/01/1998

Medical electrical equipment-Part 1: General requirements for basic safety and essential performance, Consolidated Text
standard by Association for the Advancement of Medical Instrumentation, 02/09/2006

AAMI ST59-99

September 11, 2020 By No Comments

AAMI ST59-99

September 11, 2020 By No Comments

Sterilization of Health Care Products – Biological Indicators – Part 1: General
standard by Association for the Advancement of Medical Instrumentation, 09/01/1999

Recommended practices for a medical equipment management program
standard by Association for the Advancement of Medical Instrumentation, 03/13/2013

Consideration of Unaddressed Safety Aspects in the Second Edition of IEC 60601-1 and Proposals for New Requirements
standard by Association for the Advancement of Medical Instrumentation, 11/23/2003

AAMI MEM4

September 11, 2020 By No Comments

AAMI MEM4

September 11, 2020 By No Comments

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

Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices – Part 1 and Part 2:2006
standard by Association for the Advancement of Medical Instrumentation, 03/20/2007

Testing and Reporting Performance Results of Cardiac Rhythm and ST Segment Measurement Algorithms
standard by Association for the Advancement of Medical Instrumentation, 12/18/2012

Acquisition and use of physiologic waveform databases for testing of medical devices
standard by Association for the Advancement of Medical Instrumentation, 08/18/1999

Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products.
standard by Association for the Advancement of Medical Instrumentation, 12/30/2013