Category: AAMI

Quality Management System (QMS) Recommendations on the Application of the U.S. FDA's CGMP Final Rule on Combination Products
standard by Association for the Advancement of Medical Instrumentation, 08/14/2015

Cardiac Defibrillator Devices
standard by Association for the Advancement of Medical Instrumentation, 04/01/1996

ECG TRUNK CABLES and PATIENT LEADWIRES
standard by Association for the Advancement of Medical Instrumentation, 11/19/2013

Guidance for the Validation and Routine Control of Industrial Ethylene Oxide Sterilization – Contract Sterilization
standard by Association for the Advancement of Medical Instrumentation, 02/24/1997

Medical electrical equipment – Part 2-20: Particular requirements for basic safety and essential performance of transport incubators
standard by Association for the Advancement of Medical Instrumentation, 12/09/2004

Transport Infant Incubators
standard by Association for the Advancement of Medical Instrumentation, 03/01/1997

Disposable ECG Electrodes
standard by Association for the Advancement of Medical Instrumentation, 05/03/2000

Dialysate for Hemodialysis (Includes A1:2007 and A2:2007)
standard by Association for the Advancement of Medical Instrumentation, 08/09/2004

Sterilization Pt 1: Sterilization in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 2014

Chemical sterilization and high-level disinfection in health care facilities
standard by Association for the Advancement of Medical Instrumentation, 08/21/2013

Sterilization of health care products-Radiation sterilization-Product families, sampling plans for verification dose experiments and sterilization dose audits, and frequency of sterilization dose audits
standard by Association for the Advancement of Medical Instrumentation, 01/01/2001

Selection of Surgical Gowns and Drapes in Health Care Facilities
standard by Association for the Advancement of Medical Instrumentation, 07/25/1994